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 90 STAT. 510

PUBLIC LAW 94-284—MAY 11, 1976 INFORMATION

15 USC 2055.

,

.C

DISCLOSURE

TO

OTHER

GOVERNMENTAL

BODIES

SEC. 15. Section 29 of the Consumer Product Safety Act (15 U.S.C. 2078) is amended by adding at the end thereof the following new subsection: "(e) The Commission may provide to another Federal agency or a State or local agency or authority engaged in activities relating to health, safety, or consumer protection, copies of any accident or investigation report made under this Act by any officer, employee, or agent or the Commission only if (1) information which under section 6(a)(2) is to be considered confidential is not included in any copy of such report which is provided under this subsection; and (2) each Federal agency and State and local agency and authority which is to receive under this subsection a copy of such report provides assurances satisfactory to the Commission that the identity of any injured person and any person who treated an injured person will not, without the consent of the person identified, be included in— " (A) any copy of any such report, or "(B) any information contained in any such report, which the agency or authority makes available to any member of the public. No Federal agency or State or local agency or authority may disclose to the public any information contained in a report received by the agency or authority under this subsection unless with respect to such information the Commission has complied with the applicable requirements of section 6(b).". JURISDICTION UNDER CONSUMER PRODUCT SAFETY ACT

SEC. 16. Section 30(d) of the Consumer Product Safety Act (15 U.S.C. 2079(d)) is amended to read as follows: "(d) A risk of injury which is associated with a consumer product and which could be eliminated or reduced to a sufficient extent by 15 USC 1261 action under the Federal Hazardous Substances Act, the Poison "^*Prevention Packaging Act of 1970, or the Flammable Fabrics Act t T101 t '^^y ^® regulated under this Act only if the Commission by rule finds no e, no e. ^j^^^ ^^ -^ ^^ ^^^ public interest to regulate such risk of injury under this Act. Such a rule shall identify the risk of injury proposed to be regulated under this Act and shall be promulgated in accordance with /." section 553 of title 5, United States Code; except that the period to be provided by the Commission pursuant to subsection (c) of such section for the submission of data, views, and arguments respecting the rule shall not exceed thirty days from the date of publication pursuant to subsection (b) of such section of a notice respecting the rule.". EFFECT ON STATE LAW

15 USC 1261 note. 15 USC 1261, 1262.

SEC. 17. (a) Section 18(b) of the Federal Hazardous Substances Act is amended to read as follows: " (b)(1)(A) Except as provided in paragraphs (2) and (3), if a hazardous substance or its packaging is subject to a cautionary labeling requirement under section 2(p) or 3 (b) designed to protect against a risk of illness or injury associated with the substance, no State or political subdivision of a State may establish or continue in effect a cautionary labeling requirement applicable to such substance or packaging and designed to protect against the same risk of illness or injury unless such cautionary labeling requirement is identical to the labeling requirement under section 2(p) or 3 (b).

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 PUBLIC LAW 94-284—MAY 11, 1976

90 STAT. 511

"(B) Except as provided in paragraphs (2), (3), and (4), if under regulations of the Commission promulgated under or for the enforcement of section 2(q) a requirement is established to protect against a 15 USC 1262. risk of illness or injury associated with a hazardous substance, no State or political subdivision of a State may establish or continue in effect a rec^uirement applicable to such substance and designed to protect against the same risk of illness or injury unless such requirement is identical to the requirement established under such regulations. "(2) The Federal Government and the government of any State or political subdivision of a State may establish and continue in effect a requirement applicable to a hazardous substance for its own use (or to the packaging of such a substance) which requirement is designed to protect against a risk of illness or injury associated with such substance and which is not identical to a requirement described in paragraph (1) applicable to such substance (or packaging) and designed to protect against the same risk of illness or injury if the Federal, State, or political subdivision requirement provides a higher degree of protection from such risk of illness or injury than the requirement described in paragraph (1). "(3)(A) Upon application of a State or political subdivision of a State, the Commission may, by regulation promulgated in accordance with subparagraph (B), exempt from paragraph (1), under such conditions as may be prescribed in such regulation, any requirement of such State or political subdivision designed to protect against a risk of illness or injury associated with a hazardous substance if— "(i) compliance with the requirement would not cause the hazardous substance (or its packaging) to be in violation of the applicable requirement described in paragraph (1), and "(ii) the State or political subdivision requirement (I) provides a significantly higher degree of protection from such risk of illness or injury than the requirement described in paragraph (1), and (II) does not unduly burden interstate commerce. In determining the burden, if any, of a State or political subdivision requirement on interstate commerce the Commission shall consider and make appropriate (as determined by the Commission in its discretion) findings on the technological and economic feasibility of complying with such requirement, the cost of complying with such requirement, the geographic distribution of the substance to which the requirement would apply, the probability of other States or political subdivisions applying for an exemption under this paragraph for a similar requirement, and the need for a national, uniform requirement under this Act for such substance (or its packaging). "(B) A regulation under subparagraph (A) granting an exemp- Notice; oral tion for a requirement of a State or political subdivision of a State presentation of may be promulgated by the Commission only after it has provided, views. in accordance with section 553(b) of title 5, United States Code, notice with respect to the promulgation of the regulation and has provided opportunity for the oral presentation of views respecting its promulgation. "(4) Paragraph (1)(B) does not prohibit a State or a political subdivision of a State from establishing or continuing in effect a requirement which is designed to protect against a risk of illness or injury associated with fireworks devices or components thereof and which provides a higher degree of protection from such risk of illness or injury than a requirement in effect under a regulation of the Commission described in such paragraph.

89-194 O—78—Dt. 1

36

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license: Creative Commons - Attribution Share-Alike - https://creativecommons.org/licenses/by-sa/4.0/


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 PUBLIC LAW 94-284—MAY 11, 1976

90 STAT. 512 'Commission."

"(5) As used in this subsection, the term 'Commission' means the Consumer Product Safety Commission.". (b) Section 16 of the Flammable Fabrics Act (15 U.S.C. 1203) is amended to read as follows: ((PREEMPTION "SEC. 16. (a) Except as provided in subsections (b) and (c), whenever a flammability standard or other regulation for a fabric, related material, or product is in effect under this Act, no State or olitical subdivision of a State may establish or continue in effect a ammability standard or other regulation for such fabric, related material, or product if the standard or other regulation is designed to protect against the same risk of occurrence of fire with respect to which the standard or other regulation under this Act is in effect unless the State or political subdivision standard or other regulation is identical to the Federal standard or other regulation. "(b) The Federal Government and the government of any State or political subdivision of a State may establish and continue in effect a flammability standard or other regulation applicable to a fabric, related material, or product for its own use which standard or other I'egulation is designed to protect against a risk of occurrence of fire with respect to which a flammability standard or other regulation is in effect under this Act and which is not identical to such standard or other regulation if the Federal, State, or political subdivision standard or other regulation provides a higher degree of protection from such risk of occurrence of fire than the standard or other regulation in effect under this Act. "(c)(1) Upon application of a State or political subdivision of a State, the Commission may, by regulation promulgated in accordance with paragraph (2), exempt from subsection (a), under such conditions as may be prescribed in such regulation, any flammability standard or other regulation of such State or political subdivision applicable to a fabric, related material, or product subject to a standard or other regulation in effect under this Act, if— "(A) compliance with the State or political subdivision requirement would not cause the fabric, related material, or product to be in violation of the standard or other regulation in effect under this Act, and "(B) the State or political subdivision standard or other regulation (i) provides a significantly higher degree of protection from the risk of occurrence of fire with respect to which the Federal standard or other regulation is in effect, and (ii) does not unduly burden interstate commerce. In determining the burden, if any, of a State or political subdivision flammability standard or other regulation on interstate commerce the Commission shall consider and make appropriate (as determined by the Commission in its discretion) findings on the technological and economic feasibility of complying with such flammability standard or other regulation, the cost of complying with such flammability standard or other regulation, the geographic distribution of the fabric, related material, or product to which the flammability standard or other regulation would apply, the probability of other States or political subdivisions applying for an exemption under this subsection for a similar flammability standard or other regulation, and the need for a national, uniform iflammability standard or other regulation under this Act for such fabric, related material, or product.

P

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 PUBLIC LAW 94-284—MAY 11, 1976 " (2) A regulation under paragraph (1) g r a n t i n g an exemption for a flammability standard or other regulation of a State or political subdivision of a State may be promulgated by the Commission only after it has provided, in accordance with section 553(b) of title 5, United States Code, notice with respect to the promulgation of the regulation and has provided opportunity for the oral presentation of views respecting its promulgation. " (d) For purposes of this section— " (1) a reference to a flammabilitj;' standard or other regulation for a fabric, related material, or product in effect under this Act includes a standard of flammability continued in effect by section 11 of the Act of December 14, 1967 (Public Law 90-189); and " (2) the term 'Commission' means the Consumer P r o d u c t Safety Commission.". (c) Section 8 of the Poison Prevention P a c k a g i n g Act of 1970 (15 U.S.C. 1476) is amended (1) by striking out "Whenever" and inserting in lieu thereof " (a) Except as provided in subsections (b) and (c), whenever", and (2) by adding a t the end thereof the following: " (b) The Federal Government and the government of any State or political subdivision of a State may establish and continue in effect, with respect to a household substance for its own use, a standard for special packaging or related requirement which is designed to protect against a risk of illness or injury with respect to which a standard for special packaging or related requirement is in effect under this Act and which is not identical to such standard or requirement if the Federal, State, or political subdivision standard or requirement provides a higher degree of protection from such risk of illness or injury than the standard or requirement in effect under this Act. " (c)(1) Upon application of a State or political subdivision of a State, the Commission may, by regulation promulgat-ed in accordance with paragraph (2), exempt from subsection (a), under such conditions as may be prescribed in such regulation, any standard for special packaging or related requirement of such State or political subdivision applicable to a household substance subject to a standard or requirement in effect under this Act if— " (A) compliance with the State or political subdivision standard or requirement would not cause the household substance to be in violation of the standard or requirement in effect under this Act, and " (B) the State or political subdivision standard or requirement (i) provides a significantly higher degree of protection from the risk of illness or injury with respect to which the Federal standard or requirement is in effect, and (ii) does not unduly burden interstate commerce. I n determining the burden, if any, of a State or political subdivision standard or requirement on interstate commerce the Commission shall consider and make a p p r o p r i a t e (as determined by the Commission in its discretion) findings on the technological and economic feasibility of complying with such standard or requirement, the cost of complying with such standard or requirement, the geographic distribution of the household substance to which the standard or requirement would apply, the probability of other States or political subdivisions applying for an exemption under this subsection for a similar standard or requirement, and the need for a national, uniform standard or requirement under this Act for such household substance. " (2) A regulation under paragraph (1) g r a n t i n g an exemption for a standard or requirement of a State or political subdivision of a State

90 STAT. 513 Notice; oral presentation of views.

Flammability standard or regulation.

15 USC 1191 note. "Commission.'

Notice; oral presentation of views.

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 90 STAT. 514

PUBLIC LAW 94-284—MAY 11, 1976 may be promulgated by the Commission only after it has provided, in accordance with section 553(b) of title 5, United States Code, notice with respect to the promulgation of the regulation and has provided opportunity for the oral presentation of views respecting its promulgation.". (d) Subsections (b) and (c) of section 26 of the Consumer Product Safety Act (15 U.S.C. 2075) are amended to read as follows: "(b) Subsection (a) of this section does not prevent the Federal Government or the government of any State or political subdivision of a State from establishing or continuing in effect a safety requirement applicable to a consumer product for its own use which requirement is designed to protect against a risk of injury associated with the product and which is not identical to the consumer product safety standard applicable to the product under this Act if the Federal, State, or political subdivision requirement provides a higher degree of protection from such risk of injury than the standard applicable under this Act. "(c) Upon application of a State or political subdivision of a State, the Commission may by rule, after notice and opportunity for oral presentation of views, exempt from the provisions of subsection (a) (under such conditions as it may impose in the rule) any proposed safety standard or regulation which is described in such application and which is designed to protect against a risk of injury associated with a. consumer product subject to a consumer product safety standard under this Act if the State or political subdivision standard or regulation— "(1) provides a significantly higher degree of protection from such risk of injury than the consumer product safety standard under this Act, and "(2) does not unduly burden interstate commerce. In determining the burden, if any, of a State or political subdivision standard or regulation on interstate commerce, the Commission shall consider and make appropriate (as determined by the Commission in its discretion) findings on the technological and economic feasibility of complying with such standard or regulation, the cost of complying with such standard or regulation, the geographic distribution of the consumer product to which the standard or regulation would apply, the probability of other States or political subdivisions applying for an exemption under this subsection for a similar standard or regulation, and the need for a national, uniform standard under this Act for such consumer product.". TITLE

18 PROTECTIOISr

SEC. 18. Section 1114 of title 18, United States Code, is amended by inserting ", the Consumer Product Safety Commission," immediately after "Department of Health, Education, and Welfare". FLAMMABLE FABRICS ACT ADVISORY COMMITTEE

Membership.

SEC. 19. Section 17(a) of the Flammable Fabrics Act (15 U.S.C. 1204(a)) is amended by inserting after the first sentence the following new sentence: "The members of the Committee who are appointed to represent manufacturers shall include representatives from (1) the natural fiber producing industry, (2) the manmade fiber producing industry, and (3) manufacturers of fabrics, related materials, apparel, or interior furnishings.".

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Page:United States Statutes at Large Volume 90 Part 1.djvu/565

 PUBLIC LAW 94-284—MAY 11, 1976

90 STAT. 515

FLAMMABILITY STANDARDS AND REGULATIONS

20. (t L)(1) Subsection (d) of section 4 of the Flammable Fabrics Act (16 U. T.S.C. 1193 (d)) is amended to read as follows: " (d) Standards, regulations, and amendments to standards and regulations under this section shall be made in accordance with section 553 of title 5, United States Code, except that interested persons shall be given an opportunity for the oral presentation of data, views, or arguments in addition to an opportunity to make written submissions. A transcript shall be kept of any oral presentation.". (2) Subsection (e)(3) of section 4 of such Act is amended by adding at the end thereof the following: "The standard or regulation shall not be affirmed unless the findings required by the first sentence of subsection (b) are supported by substantial evidence on the record taken as a whole. For purposes of this paragraph, the term 'record' means "Record. the standard or regulation, any notice published with respect to the promulgation of such standard or regulation, the transcript required by subsection (d) of any oral presentation, any written submission of interested parties, and any other information which the Commission considers relevant to such standard or regulation.". (b) The amendments made by subsection (a) shall apply with Effective date. respect to standards, regulations, and amendments to standards and 15 USC 1193 regulations, under section 4 of the Flammable Fabrics Act the pro- note. ceedings for the promulgation of which were begun after the date of 15 USC 1193. the enactment of this Act. SEC.

Approved May 11, 1976.

LEGISLATIVE HISTORY: HOUSE REPORTS: No. 94-325 accompanying H.R. 6844 (Comm. on Interstate and Foreign eommerce) and No. 94-1022 (Comm. of eonference). SENATE REPORT No. 94-251 (Comm. on eommerce). CONGRESSIONAL RECORD: Vol. 121 (1975): July 18, considered and passed Senate. July 28, 29, Sept. 24, 26, Oct. 22, considered and passed House, amended, in lieu of H.R. 6844. Vol. 122 (1976): Apr. 13, House agreed to conference report. Apr. 28, Senate agreed to conference report. WEEKLY eOMPILATION OF PRESIDENTIAL DOeUMENTS: Vol. 12, No. 20 (1976): May 12, Presidential statement.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/566

 90 STAT. 516

PUBLIC LAW 94-285—MAY 12, 1976

Public Law 94-285 94th Congress An Act May 12, 1976 [H.R. 11876] Water Resources Planning Act, appropriation authorization. 42 USC 1962d.

To amend the Water Resources Planning Act (79 Stat. 244) as amended.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That the Water Kesources Planning Act of 1965 (79 Stat. 244, as amended) is hereby further amended by deleting, in section 401(b), the words "not to exceed $1,500,000" and inserting in lieu thereof the words "not to exceed $2,000,000". SEC. 2. Section 306 of the Water Resources Planning Act (79' Stat. 244, 253; 42 U.S.C. 1962c-5) is amended by deleting "or the Virgin Islands." and interesting in lieu thereof "the Virgin Islands or Ghiam.". Approved May 12, 1976.

LEGISLATIVE HISTORY: HOUSE REPORT No. 94-983 (Comm. on Interior and Insular Affairs). SENATE REPORT No. 94-768 (Comm. on Interior and Insular Affairs). CONGRESSIONAL RECORD, Vol. 122 (1976): Apr. 5, considered and passed House. May 3, considered and passed Senate.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/567

 PUBLIC LAW 94-286—MAY 14, 1976

90 STAT. 517

Public Law 94-286 94th Congress An Act To amend chapter 39 of title 10, United States Code, to enable the President to authorize the involuntary order to active duty of Selected Reservists, for a limited period, whether or not a declaration of war or national emergency has been declared.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That chapter 39 of title 10, United States Code, is amended by inserting the following new section after section 67'3a and inserting a corresponding item in the chapter analysis: "§ 673b. Selected Reserve; order to active duty other than during war or national emergency "(a) Notwithstanding the provisions of section 673(a) or any other provision of law, when the President determines that it is necessary to augment the active forces for any operational mission, he may authorize the Secretary of Defense and the Secretary of Transportation with respect to the Coast Guard when it is not operating as a service in the Navy, without the consent of the members concerned, to order any unit, and any member not assigned to a unit organized to serve as a unit, of the Selected Reserve (as defined in section 268(b) of this title), under their respective jurisdictions, to active duty (other than for training) for not more than 90 days. "(b) No unit or member of a Reserve component may be ordered to active duty under this section to perform any of the functions authorized by chapter 15 or section 3500 or 8500 of this title, or to provide assistance to either the Federal Government or a State in time of a serious natural or manmade disaster, accident, or catastrophe. "(c) Not more than 50,000 members of the Selected Reserve may be on active duty under this section at any one time. "(d) Members ordered to active duty under this section shall not be counted in computing authorized strength in members on active duty or members in grade under this title or any other law. "(e) The Secretary of Defense and the Secretary of Transportation shall prescribe such policies and procedures for the Armed Forces under their respective jurisdictions as they consider necessary to carry out this section. "(f) Whenever the President authorizes the Secretary of Defense or the Secretary of Transportation to order any unit or member of the Selected Reserve to active duty, under the authority of subsection (a), he shall, within 24 hours after exercising such authority, submit to the Speaker of the House of Representatives and to the President pro tempore of the Senate a report, in writing, setting forth the circumstances necessitating the action taken under this section and describing the anticipated use of these units or members. "(g) Whenever any unit of the Selected Reserve or any member of the Selected Reserve not assigned to a unit organized to serve as a unit is ordered to active duty under authority of subsection (a),

May 14, 1976 [S. 21151

Armed Forces. Selected Reserve, involuntary order to active duty. 10 USC 673b.

10 USC 331, 3500, 8500.

Policies and procedures.

Report to Congress.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/568

 90 STAT. 518

i Remployment rights.

.^'

PUBLIC LAW 94-286—MAY 14, 1976 the service of all units or members so ordered to active duty may be terminated by— "(1) order of the President, or " (2) a concurrent resolution of the Congress. "(h) Nothing contained in this section shall be construed as amending or limiting the application of the provisions of the War Powers Resolution.". SEC. 2. Section 2024 of title 38, United States Code, is amended by adding the following new subsection after subsection (f): "(g) Any member of a Reserve component of the Armed Forces of the United States who is ordered to active duty for not more than 90 days under section 673b of title 10, United States Code, whether or not voluntarily, shall be entitled to all reemployment rights and benefits provided under subsection (c) of this section for persons ordered to an initial period of active duty for training of not less than three consecutive months; and shall have the service limitation governing eligibility for reemployment rights under subsections (a) and (b)(1) of this section extended by his period of such active duty." Approved May 14, 1976.

l:-i!R,-r.,

LEGISLATIVE HISTORY: HOUSE REPORT No. 94-1069 (Comm. on Armed Services). SENATE REPORT No. 94-562 (Comm. on Armed Services). " ' CONGRESSIONAL RECORD, Vol. 122 (1976): Jan. 26, considered and passed Senate. May 3, considered and passed House. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 12, No. 21: May 14, Presidential statement.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/569

 PUBLIC LAW 94-287—MAY 21, 1976

90 STAT. 519

Public Law 94-287 94th Congress An Act To authorize the erection of a statue of Bernardo de Galvez on public grounds in the District of Columbia.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled., That the Secretary of the Interior shall select an appropriate site for the location of a statue, including pedestal therefor, of Bernardo de Galvez, a gift of the Government of Spain in recognition of the Bicentennial celebrations of the United States of America and as a token of the friendship that exists between the people of Spain and the people of the United States. Such statue shall be erected on grounds now owned by the United States of America in the District of Columbia if (1) the choice of the site and the design of the statue is approved by the Commission of Fine Arts and the National Capital Planning Commission, and (2) the erection of the statue is begun within five years after the date of the enactment of this Act. The erection of the statue and proper landscape treatment of the site, including walks, shall be without expense to the United States of America, except for necessary maintenance after completion. Approved May 21, 1976.

LEGISLATIVE HISTORY: SENATE REPORT No. 94-775 (Comm. on Interior and Insular Affairs). CONGRESSIONAL RECORD, Vol. 122 (1976): May 5, considered and passed Senate. May 10, considered and passed House, in lieu of H.R. 11844.

May 21. 1976 [S. 3031]

Bernardo de Galvez. Statue, erection in D.C.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/570

 90 STAT. 520

PUBLIC LAW 94-288—MAY 21, 1976

Public Law 94-288 94th Congress

v8!

An Act May 21, 1976 [H.R. 12018]

Helen Keller National Center for Deaf-Blind Youths and Adults. Designation.

To amend the Rehabilitation Act of 1973 to provide that the center for deaf-blind youths and adults established by such Act shall be known as the Helen Keller National Center for Deaf-Blind Youths and Adults.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That (a) section 305 of the Rehabilitation Act of 1973 (29 U.S.C. 775), hereinafter in this Act referred to as the "Act", is amended by inserting "Helen Keller" immediately before "National Center" each place it appears therein. (b) The second sentence of section 305(c) of the Act (29 U.S.C. 775(c)) is amended by striking out "such" the second place it appears therein and inserting ni lieu thereof "the Helen Keller National. SEC. 2. The heading for section 305 of the Act (29 U.S.C. 775) is amended to read as follows: u H E L E N KELLER NATIONAL CENTER TOR DEAF-BLIND YOUTHS AND ADULTS?9

Approved May 21, 1976. ' ]

LEGISLATIVE HISTORY: CONGRESSIONAL RECORD, Vol. 122 (1976): May 3, considered and passed House. May 6, considered and passed Senate.

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 PUBLIC LAW 94-289—MAY 22, 1976

90 STAT. 521

Public Law 94-289 94th Congress An Act To provide for adjusting the amount of interest paid on funds deposited with the Treasury of the United States by the Library of Congress Trust Fund Board.

Be it enacted by the Senate and House of Representatives of the United States of America vti Congress assembled, That section 2 of the Act of March 3, 1925, chapter 423, as renumbered by the Act of April 13, 1936, chapter 213 (2 U.S.C. 158), is amended by striking out "the rate of 4 per centum per annum," and inserting in place thereof "a rate which is the higher of the rate of 4 per centum per annum or a rate which is 0.25 percentage points less than a rate determined by the Secretary of the Treasury, taking into consideration the current average market yield on outstanding long-term marketable obligations of the United States, adjusted to the nearest one-eighth of 1 per centum,*'. Approved May 22, 1976.

LEGISLATIVE HISTORY: HOUSE REPORT No. 94^737 accompanying H.R. 8627 (Comm. on House Administration). SENATE REPORT No. 94-^189 (Comm. on Rules and Administration). CONGRESSIONAL RECORD: VoL 121 (1975): Dec. 1, considered and passed Senate. VoL 122 (1976): Feb. 2, considered and passed House, amended, in lieu of H.R. 8627. Mar. 16, Senate concurred in House amendment with an amendment. May 10, House concurred in Senate amendment.

May 22, 197o [S. 2619]

Library of Congress trust { " * deposits. "< i^^y^tment J ™ •

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 90 STAT. 522

PUBLIC LAW 94-290—MAY 22, 1976

Public Law 94-290 94th Congress An Act May 22, 1976 [S. 2620]

Gertrude M. Hubbard trust fund deposits. Interest adjustment.

To provide for adjusting the amount of interest paid on funds deposited with the Treasury of the United States pursuant to the Act of August 20, 1912 (37 Stat. 319).

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 3 of the Act entitled "An Act to accept and fund the bequest of Gertrude M. Hubbard", approved August 20, 1912 (37 Stat. 320) is amended to read as follows: "SEC. 3. In compliance with said conditions the principal of the sum so received and paid into the Treasury of the United States shall be credited on the books of the Treasury Department as a perpetual trust fund; and the Secretary of the Treasury shall thereafter credit such deposit with interest, semiannually, at a rate which is the higher of (1) a rate which is 0.25 percentage points less than a rate determined by the Secretary of the Treasury, taking into consideration the current average market yield on outstanding long-term marketable obligations of the United States, adjusted to the nearest one-eighth of 1 per centum, or (2) the rate of 4 per centum per annum; and such interest, as income, shall be subject to disbursement for the purposes herein authorized and as provided in the said bequest.". Approved May 22, 1976.

LEGISLATIVE HISTORY: HOUSE REPORT No. 94-738 accompanying H.R. 8628 (Comm. on House Administration). SENATE REPORT No. 94-488 (Comm. on Rules and Administration). CONGRESSIONAL RECORD: Vol. 121 (1975): Dec. 1, considered and passed Senate. Vol. 122 (1976): Feb. 2, considered and passed House, amended, in lieu of H.R. 8628. Mar. 16, Senate concurred in House amendment with an amendment. May 10, House concurred in Senate amendment.

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 PUBLIC LAW 94-291—MAY 22, 1976

90 STAT. 523

Public Law 94-291 94th Congress An Act To authorize appropriations to the Nuclear Regulatory Commission in accordance with section 261 of the Atomic Energy Act of 1954, as amended, and section 305 of the Energy Reorganization Act of 1974, as amended, and for other purposes.

May 22. 1976 [S. 3107]

Be it enacted by the Senate and House of Representatives of the Nuclear United States of America in Congress assembled, SEC. 101. There is hereby authorized to be appropriated to the Regulatory Nuclear Regulatory Commission in accordance with the provisions Commission. of section 261 of the Atomic Energy Act of 1954, as amended, and Appropriation authorization. section 305 of the Energy Reorganization Act of 1974, as amended; 42 USC 2017. for salaries and expenses, $274,300,000 to remain available until 42 USC 5875. expended. SEC. 102. Moneys received by the Commission for the cooperative Moneys for nuclear safety research programs may be retained and used for salaries research and expenses associated with those programs, notwithstanding the programs, use. provisions of section 3617 of the Revised Statutes (31 U.S.C. 484), and shall remain available until expended. Funds may be obligated for purposes stated in this section only to the extent provided in appropriation Acts. SEC. 103. Transfers of sums from salaries and expenses may be Transfer of sums. made to other agencies of the Government for the performance of the work for which the appropriation is made, and in such cases the sums so transferred may be merged with the appropriation to which transferred. AMENDMENTS TO PRIOR TEAR ACT

SEC. 104. (a) Title I of Public Law 94-79 is amended by adding 89 Stat. 413. section 102 to read as follows: "Moneys received by the Commission for the cooperative nuclear research program may be retained and used for salaries and expenses associated with that program, notwithstanding the provisions of section 3617 of the Revised Statutes (31 U.S.C. 484), and shall remain available until expended. Funds may be obligated for purposes stated in this section only to the extent provided in appropriation Acts.". (b) Section 101 of Public Law 94-79 is amended by adding the phrase "and shall remain available until expended" after the words "September 30, 1976". Approved May 22, 1976.

LEGISLATIVE HISTORY: HOUSE REPORT No. 94-1079 accompanying H.R. 12387 (Joint Coram, on Atomic Energy). SENATE REPORT No. 94-772 (Joint Coram, on Atomic Energy). CONGRESSIONAL RECORD, Vol. 122 (1976): May 5, considered and passed Senate. May 10, considered and passed House, in lieu of H.R. 12387.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/574

 90 STAT. 524

PUBLIC LAW 94-292—MAY 27, 1976

Public Law 94-292 94th Congress An Act May 27, 1976 [H.R. 8957] Civil Rights Commission Authorization Act of 1976. 42 USC 1975e note.

To raise the limitation on appropriations for the United States Commission on Civil Rights.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Civil Rights Commission Authorization Act of 1976". SEC. 2. Section 106 of the Civil Rights Act of 1957 (42 U.S.C. 1975e) is amended to read as follows: "SEC. 106. For the purposes of carrying out this Act, there is hereby authorized to be appropriated for the fiscal year ending June 30, 1976, the sum of $7,893,000, and for the period beginning July 1, 1976, and ending September 30, 1976, the sum of $1,993,000, and for the fiscal year ending September 30, 1977, the sum of $9,540,000, and such additional amounts for those fiscal years and period prior to October 1, 1977, as may be necessary for increases in salary^, pay, retirement, and other employee benefits authorized by law which arise subsequent to the date of the enactment of the Civil Rights Commission Authorization Act of 1976.". Approved May 27, 1976.

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LEGISLATIVE HISTORY: SENATE REPORT No. 94-811 (Coram, on the Judiciary). CONGRESSIONAL RECORD, Vol. 122 (1976): Apr. 5, considered and passed House. May 13, considered and passed Senate.

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 PUBLIC LAW 94-293—MAY 27, 1976

90 STAT. 525

Public Law 94-293 94th Congress An Act To amend the Domestic Volunteer Service Act of 1973 to extend the operation of certain programs by the ACTION Agency.

May 27, 1976 [H.R. 12216]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may Domestic be cited as the "Domestic Volunteer Service Act Amendments of 1976" Volunteer Service SEC. 2. Section 114(a) of the Domestic Volunteer Service Act ol Act Amendments 1973 (hereinafter in this Act referred to as the "Act") is amended by of 1976. 4951 42 USC inserting at the end thereof the following new sentence: "In any fiscal note. year in which the funds appropriated for the purposes of the Univer- 42 OSC 4974. sity Year for ACTION program under section 112 exceed $6,700,000, 42 USC 4972. the limitation provided in the preceding sentence shall not apply with respect to that portion of such appropriation which exceeds $6,700,000.". SEC. 3. (a) Section 122(c) of the Act is amended by adding at the 42 USC 4992. end thereof the following new sentence: "The Director is autnorized to undertake and support volunteer service programs, and to recruit, select, and train volunteers to carry out the purpose of this part.". (b)(1) Part C of title I of the Act is amended by adding at the end thereof the following new section: TECHNICAL AND F I N A N C I A L ASSISTANCE FOR IMPROVEMENT OF VOLUNTEER PROGRAMS

"SEC. 123. The Director may provide technical and financial assist- 42 USC 4993. ance to Federal agencies, State and local governments and agencies, and private nonprofit organizations, which utilize or desire to utilize volunteers in connection with carrying out the purpose of this part. Such assistance may be used to facilitate and improve (1) methods of recruiting, training, or utilizing volunteers, or (2^ the administration of volunteer programs. In providing such technical and financial assistance, the Director shall utilize, to the maximum extent feasible, existing programs, and shall seek to avoid duplication of existing programs in the public or private sectors.". (2) The table of contents for the Act is amended by inserting immediately after the item relating to section 122 the following new item: "Sec. 123. Technical and financial assistance for improvement of volunteer programs.".

SEC. 4. (a)(1) Part A of title I of the Act is amended by adding at the end thereof the following new section: u LIMITATIONS

"SEC. 108. Of funds appropriated for the purpose of this part under 42 USC 4958. section 501, not more than 20 per centum for the fiscal year ending 42 USC 5081. September 30, 1977, and for each fiscal year thereafter, may be obligated for the direct cost of supporting volunteers in programs or projects carried out pursuant to grants and contracts made under section 402 (12).". 42 USC 5042.

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90 STAT. 526

(2) The table of contents for the Act is amended by inserting immediately after the item relating to section 107 the following new item: "Sec.

42 USC 5042. Effective date.

42 USC 4958 note.

42 USC 5045.

Repeal. 42 USC 5053. 42 USC 5081.

42 USC 5083.

42 USC 5084.

42 USC 5011. Person-to-person services to children.

108. Limitations.",

(b) Section 402 (12) of the Act is amended by striking o u t " (except for volunteers serving under part A of title I thereof)" and inserting in lieu thereof "(except as provided in section 108)". (c) The amendments made by subsection (a) and subsection (b) of this section shall be effective on October 1, 1976, and shall not apply to any agreement for the assignment of volunteers entered into before such date during the period of any such agreement. SEC. 5. (a) Section 405 of the Act is amended by adding at the end thereof the following new subsection: "(d) In the event that a National Advisory Council to the ACTION Agency is established by administrative action after January 1, 1976, the provisions of subsections (a), (b), and (c) of this section shall apply to any such Council.". (h)(1) Title IV of the Act is amended by striking out section 413. (2) The table of contents for the Act is amended by striking out the item relating to section 413. SEC. 6. (a) Section 501(a) of the Act is amended by striking out "and" immediately after "June 30, 1975," and by inserting immediately after "June 30, 1976," the following: "September 30, 1977, and September 30, 1978,". (b) Section 503 of the Act is amended by striking out "and" immediately after "June 30, 1975," and by inserting immediately after "June 30, 1976," the following: "September 30, 1977, and September 30, 1978,". (c) Section 504 of the Act is amended by striking out "and" immediately after "June 30, 1975," and by inserting immediately after "June 30, 1976," the following: "September 30, 1977, and September 30, 1978,". SEC. 7. Section 211 of the Act is amended by adding at the end thereof the following new subsections: "(c)(1) Any public or private nonprofit agency or organization responsible for providing person-to-person services to a child in a project carried out under subsection (a) of this section shall have the exclusive authority to determine, pursuant to the provisions of paragraph (2) of this subsection— "(A) which children may receive supportive person-to-person services under such project; and "(B) the period of time during which such services shall be continued in the case of each individual child. "(2) In the event that such an agency or organization determines that it is in the best interests of a mentally retarded child receiving, and of a particular foster grandparent providing, services in such a project, such relationship may be continued after the child reaches the chronological age of 21: Provided, That such child was receiving such services prior to attaining the chronological age of 21.

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 PUBLIC LAW 94-293—May 27, 1976

90 STAT. 527

"(3) Any determination made by a public or nonprofit private agency or organization under paragraphs (1) and (2) of this subsection shall be made through mutual agreement by all parties involved with respect to the provision of services to the child involved. "(d) For the purposes of this section, the terms 'child' and 'children' "Child" and mean any individual or individuals who are less than 21 years of age.", "children." Approved May 27, 1976.

LEGISLATIVE HISTORY: CONGRESSIONAL RECORD, Vol. 122 (1976): May 4, considered and passed House. May 13, considered and passed Senate.

89-194 0—7ft_nt 1

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 PUBLIC LAW 94-294—MAY 28, 1976

Public Law 94-294 94th Congress

90 STAT. 529

^&.

An Act To enable cattle producers to establish, finance, and carry out a coordinated program of research, producer and consumer information, and promotion to improve, maintain, and develop markets for cattle, beef, and beef products.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act shall be known as the "Beef Research and Information Act". LEGISLATIVE FINDINGS AND DECLARATION OF POLICY

SEC. 2. Beef constitutes one of the basic, natural foods in the diet. It is produced by many individual cattle producers throughout the United States. Cattle, beef, and beef products move in interstate and foreign commerce and those which do not move in such channels of commerce directly burden or affect interstate commerce of cattle, beef, and beef products. The maintenance and expansion of existing markets and the development of new or improved markets and uses are vital to the welfare of cattle producers and those concerned with marketing, using, and processing beef as well as the general economy of the Nation. The production and marketing of cattle, beef, and beef products by numerous individual persons in the cattle and beef industry have prevented the development and carrying out of adequate and coordinated programs of research, information, and promotion necessary for the maintenance of markets and the development of new products of, and markets for cattle, beef, or beef products. Without an effective and coordinated method for assuring cooperative and collective action in providing for and financing such programs, individual cattle producers are unable to provide, obtain, or carry out the research, consumer and producer information, and promotion necessary to maintain and improve markets for cattle, beef, and beef products. It has long been recognized that it is in the public interest to provide an adequate, steady supply of high quality beef and beef products readily available to the consumers of the Nation. Maintenance of markets and the development of new markets, both domestic and foreign, are essential to the cattle industry if the consumers of beef and beef products are to be assured of an adequate, steady supply of such products at reasonable prices. I t is therefore declared to be the policy of the Congress and the purpose of this Act that it is essential and in the public interest, through the exercise of the powers provided herein, to authorize and enable the establishment of an orderly procedure for the development and the financing through an adequate assessment of an effective and continuous coordinated program of research, consumer information, producer information, and promotion designed to strengthen the cattle and beef industry's position in the marketplace, and maintain and expand domestic and foreign markets and uses for United States beef. Nothing in this Act shall be construed to mean, or provide for, control of production or otherwise limit the right of individual cattle producers to produce cattle or beef.

May 28, 1976 [H.R. 7656]

Beef Research and Information Act. 7 USC 2901 note. 7 USC 2901.

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 90 STAT. 530

PUBLIC LAW 94-294—MAY 28, 1976 DEFINITIONS

7 USC 2902.

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...

SEC. 3. As used in this Act— (a) The term "Secretary" means the Secretary of Agriculture or any other officer or employee of the Department of Agriculture to whom there has heretofore been delegated, or to whom there may hereafter be delegated, the authority to act in his stead. (b) The term "person" means any individual, group of individuals, partnership, corporation, association, cooperative, or any other entity. (c) The term "cattle" means live domesticated bovine quadrupeds. (d) The term "beef" means the flesh of cattle. (e) The term "beef products" means products produced in whole or in part from cattle, exclusive of milk and products made therefrom. (f) The term "producer" means any person who owns or acquires ownership of cattle: Provided, That a person shall not be considered to be a producer if his only share in the proceeds of a sale of cattle or beef is a sales commission, handling fee, or other service fee. (g) The term "producer-buyer" means a producer who buys cattle. (h) The term "producer-seller" means a producer who sells cattle. (i) The term "United States" means the fifty States of the United States of America and the District of Columbia. (j) The term "promotion" means any action to advance the image or desirability of beef and beef products. (k) The term "research" means any type of research to advance the desirability, marketability, production, or quality of cattle, beef, and beef products. (1) The term "consumer information" means facts, data, and other information that will assist consumers and other persons in making evaluations and decisions regarding the purchasing, preparation, and utilization of beef and beef products. (m) The term "producer information" means facts, data, and other information that will assist producers in making decisions that lead to increased efficiency, lower cost of production, a stable supply of cattle, and the development of new markets. (n) The term "marketing" means the sale or other disposition of cattle, beef, or beef products, in any channel of commerce. (o) The term "commerce" means interstate, foreign, or intrastate commerce. (p) The term "transaction" means the transfer of ownership of cattle or beef through a sale, trade, or other means of exchange. (q) The term "slaughterer" means any person, specified in the order or the rules and regulations issued thereunder, who slaughters cattle, including cattle of his own production. BEEF RESEARCH AND PROMOTION ORDER

7 USC 2903.

SEC. 4. To effectuate the declared policy of this Act, the Secretary shall, subject to the provisions of this Act, issue and from time to time amend an order applicable to producers and slaughterers. Such an order shall be applicable to all areas in the United States. NOTICE AND HEARING

7 USC 2904.

SEC. 5. Whenever the Secretary has reason to believe that the issuance of an order will tend to effectuate the declared policy of this Act, he shall give due notice and opportunity for hearing upon a proposed order. Such hearing may be requested and proposal for an order submitted by an organization certified pursuant to section 15 of this

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90 STAT. 531

Act, or by any interested person affected by the provisions of this Act, including the Secretary. F I N D I N G AND ISSUANCE OF A N ORDER

SEC. 6. After notice and opportunity for hearing as provided in Notice and section 5, the Secretary shall issue an order if he finds, and sets forth hearing. in such order, upon the evidence introduced at such hearing, that the 7 USC 2905. issuance of such order and all the terms and conditions thereof will tend to effectuate the declared policy of this Act. PERMISSIVE TERMS I N ORDER

SEC. 7. Any order issued pursuant to this Act shall contain one or more of the following terms and conditions, and except as provided in section 8, no others: (a) Providing for the establishment, issuance, effectuation, and administration of appropriate plans or projects for advertising, promotion, producer information, and consumer information with respect to the use of cattle, beef, or beef products and for the disbursement of necessary funds for such purposes: Provided, however, That any such plan or project shall be directed toward increasing the general demand for cattle, beef, or beef products. No reference to a private brand or trade name shall be made if the Secretary determines that such reference will result in undue discrimination against the cattle, beef, or beef products of other persons. No such advertising, consumer education, or sales promotion programs shall make use of false or misleading claims in behalf of cattle, beef, or beef products, or false or misleading statements with respect to quality, value, or use of any competing product. (b) Providing for, establishing, and carrying on research, market development projects, and studies with respect to sale, distribution, marketing, utilization, or production of cattle, beef, or beef products, and the creation of new products thereof, to the end that the production, marketing, and utilization of cattle, beef, or beef products may be encouraged, expanded, improved, or made more acceptable, and the data collected by such activities may be disseminated, and providing for the disbursement of necessary funds for such purposes. (c) Providing that slaughterers shall maintain and make available for the inspection such books and records as may be required by any order or regulations issued pursuant to this Act and for the filing of reports by such persons at the time, in the manner, and having content prescribed by the order or regulations to the end that information and data shall be made available to the Beef Board and to the Secretary which is appropriate or necessary to the effectuation, administration, or enforcement of the Act, or of any order or regulation issued pursuant to this Act: Provided, however. That all information so obtained shall be kept confidential by all officers and employees of the Department of Agriculture and of the Beef Board, and by all officers and employees of contracting agencies having access to such information, and only such information so furnished or acquired as the Secretary deems relevant shall be disclosed by them, and then only in a suit or administrative hearing brought at the direction, or upon the request, of the Secretary, or to which he or any officer of the United States is a party, and involving the order with reference to which the information so to be disclosed was furnished or acquired. Nothing in this section shall be deemed to prohibit (1) the issuance of general statements based upon the reports of the number of persons subject to an order or

7 USC 2906

Slaughterers, record maintenance.

Confidential information.

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 90 STAT. 532

Penalty.

PUBLIC LAW 94-294—MAY 28, 1976 statistical data collected therefrom, which statements do not identify the information furnished by any person, (2) the publication of general statements relating to refunds made by the Beef Board during any specific period, which statements do not identify any person to whom refunds are made, or (3) the publication by direction of the Secretary of the name of any person violating any order, together with a statement of the particular provisions of the order violated by such person. Any such officer or employee violating the provision of the subsection shall, upon conviction, be subjected to a fine of not more than $1,000 or to imprisonment for not more than one year, or to both, and if an officer or employee of the Beef Board or the Department of Agriculture, he shall be removed from office. (d) Teims and conditions incidental to and not inconsistent with the terms and conditions specified in this Act and necessary to effectuate the other provisions of such order. REQUIRED TERMS I N

7 USC 2907. Beef Board. Establishment.

Term.

ORDER

SEC. 8. Any order issued pursuant to this Act shall contain the following terms and conditions; (a) Providing for the establishment and appointment, by the Secretary, of a Beef Board which shall consist of not more than sixtyeight members, and alternates therefor, and defining its powers and duties which shall include only the powers (1) to administer such order in accordance with its terms and provisions, (2) to make rules and regulations to effectuate the terms and provisions of such order, (3) to receive, investigate, and report to the Secretary complaints of violations of such order, (4) to recommend to the Secretary amendments to such order. The term of an appointment to the Beef Board shall be for three yeai"S with no member serving more than six consecutive years, except that initial appointment shall be proportionately for one, two, and three years: Provided, That the Beef Board shall appoint from its members an executive committee, consisting of not less than seven nor more than eleven members who are broadly representative of the industry, with authority to employ a staff and conduct routine business within the policies determined by the Beef Board. (b) Providing that the Beef Board, and alternates therefor, shall be composed of cattle producers appointed by the Secretary from nominations submitted by eligible producer organizations, associations, general farm organizations, or cooperatives, within the geographic area, and certified pursuant to section 15, or, if the Secretary determines that substantial number of producers are not members of or their interests are not represented by any such eligible organizations, associations, or cooperatives, from nominations made by such producers in the manner authorized by the Secretary so that the representation of producers on the Board shall reflect, to the extent practicable, the proportion of cattle produced in each geographic area of the United States as defined by the Secretary: Provided, That the Beef Board shall from time to time, with the approval of the Secretary, redesignate representation on the Beef Board so as to reflect the proportion of cattle in each geographic area: Provided, however, That each such designated geographic area shall be entitled to at least one representative on the Beef Board. (c) Providing that the Beef Board shall, subject to the provisions of subsection (g) of this section, develop and submit to the Secretary for his approval any advertising, sales promotion, consumer information, producer information, research, and development plans or proj-

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 PUBLIC LAW 94-294—MAY 28, 1976 ects, and that any such plan or project must be approved by the Secretary before becoming effective. (d) Providing that the Beef Board shall, subject to the provisions of subsection (g) of this section, submit to the Secretary for his approval budgets on a fiscal period basis of its anticipated expenses and disbursements in the administration of the order, including probable costs of advertising, promotion, producer information, consumer information, research, and development projects. The Beef Board shall also submit copies of such budgets to the House Committee on Agriculture and the Senate Committee on Agriculture and Forestry. (e) Providing, that— (1) In each transaction where a producer sells or otherwise transfers ownership of cattle to any other producer, each such producer-seller shall pay to the producer-buyer and each producer-buyer shall collect from the producer-seller an assessment based on the value of the cattle involved in the transaction. Each producer who sells to a slaughterer or otherwise arranges for the slaughter of his cattle shall pay to the slaughterer and the slaughterer shall collect from such producer an assessment based on the value of the cattle involved. The slaughterer shall remit assessment (s) collected to the Beef Board in the manner prescribed by the order or the regulations issued thereunder, including any assessment(s) due at time of slaughter on cattle of his own production. In the event no sales transaction occurs at the point of slaughter, a fair value shall be attributed to the cattle at the time of slaughter for the purposes of determining the assessment: Provided, That the Beef Board may exempt from or vary the assessment on transactions of breeding animals or classes of breeding animals until time of slaughter: Provided further, That cattle slaughtered for his own home consumption by a producer who has been the sole owner of such cattle shall not be subject to assessments provided in this Act: Provided further, That the Beef Board may collect directly from any producer any assessments that he collected under the provisions of this Act, which are not passed along in the usual manner due to the loss in value of the cattle. (2) The rate of assessment shall be as prescribed by the order except the aggregate rate shall not exceed one-half of 1 percent and shall provide for such expenses and expenditures, including provision for a reasonable reserve, and any referendum and administrative costs incurred by the Secretary under this Act, as the Secretary finds are reasonable and likely to be incurred by the Beef Board under the order during any period specified by him. (3) To facilitate the collection of assessments, the Beef Board may specify different procedures for slaughterers, or classes of slaughterers, to recognize differences in marketing practices or procedures utilized in the industry. (4) The Secretary may maintain a suit against any person subject to the order for the collection of such assessment and the several district courts of the United States are hereby vested with jurisdiction to entertain such suits regardless of the amount in controversy. (f) Providing that the Beef Board shall maintain such books and records and prepare and submit such reports from time to time to the

90 STAT. 533

Budgets, submittal to Secretary and congressional committees.

Record maintenance; reports to Secretary.

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 90 STAT. 534

Contracts or agreements.

Reimbursement.

PUBLIC LAW 94-294—MAY 28, 1976 Secretary as he may prescribe, and for appropriate accounting by the Beef Board with respect to the receipt and disbursement of all funds entrusted to it. (g) Providing that the Beef Board, with the approval of the Secretary, may enter into contracts or agreements for development and carrying out the activities authorized under the order pursuant to section 7(a) and (b) and for the payment of the cost thereof with funds collected pursuant to the order. Any such contract or agreement shall provide that such contractors shall develop and submit to the Beef Board a plan or project together with a budget or budgets which shall show estimated costs to be incurred for such plan or project, and that any such plan or project shall become effective upon the approval of the Secretary, and further, shall provide that the contracting parties shall keep accurate records of all of their activities and make periodic reports to the Beef Board of activities carried out and an accounting for funds received and expended, and such other reports as the Secretary may require. (h) Providing that no funds collected by the Beef Board under the order shall in any manner be used for the purpose of influencing governmental policy or action, except as provided by subsection (a)(4) of this section. (i) Providing the Beef Board members, and alternates therefore, shall serve without compensation, but shall be reimbursed for their reasonable expenses incurred in performing their duties as members of the Beef Board. REQUIREMENT OF REFERENDUM AND CATTLE PRODUCER APPROVAL

7 USC 2908.

Notice.

"Expenses incurred for the conduct of the referendum."

SEC. 9. The Secretary shall conduct a referendum as soon as practicable among producers who at any time, during a consecutive twelvemonth representative period preceding the date of the referendum, as determined by the Secretary, have been engaged in the production of cattle for the purpose of ascertaining whether the issuance of an order is approved or favored by such producers. The Secretary shall establish a procedure whereby all known cattle producers are notified of the referendum and the time and place of balloting and qualified producers may register with the Agriculture Stabilization and Conservation Service in person or by mail to vote in such a referendum during a period ending not less than ten days prior to the date of the referendum. No order issued pursuant to this Act shall be effective unless the Secretary determines (1) that votes were cast by at least 50 per centum of the registered producers, and (2) that the issuance of such order is approved or favored by not less than two-thirds of the producers voting in such referendum. The Secretary shall be reimbursed from assessments collected by the Beef Board for any expenses incurred for the conduct of the referendum. Eligible voter lists and ballots cast in the referendum shall be retained by the Secretary for a period of not less than twelve months after they are cast for audit and recount in the event the results of the referendum are challenged and either the Secretary or the Courts determine a recount and retabulation of results is appropriate. Prior to the holding of the referendum, sureties shall have posted a bond or other security, acceptable to the Secretary, in an amount which the Secretary shall determine to be sufficient to pay any expenses incurred for the conduct of the referendum. For the purpose of this section, the term "expenses incurred for the conduct of the referendum" shall include all costs incurred by the Government in connection therewith, except for salaries of Government employees.

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SUSPENSION AND TERMINATION OF ORDERS

SEC. 10. (a) The Secretary shall, whenever he finds that any order 7 USC 2909. issued under this Act, or any provisions) thereof, obstructs or does not tend to effectuate the declared policy of this Act, terminate or suspend the operation of such order or such provision (s) thereof. (b) The Secretary may conduct a referendum at any time, and shall Referendum, hold a referendum on request of 10 per centum or more of the number of producers voting in the referendum approving the order, to determine whether such producers favor the termination or suspension of the order, and he shall suspend or terminate such order six months after he determines that suspension or termination of the order is approved or favored by a majority of the producers voting in such referendum who, during a representative period determined by the Secretary, have been engaged in the production of cattle, and who produced more than 50 per centum of the volume of cattle produced by the producers voting in the referendum. (c) The termination or suspension of any order, or any provision thereof, shall not be considered an order within the meaning of this Act. PROVISIONS APPLICABLE TO AMENDMENTS

SEC. 11. The provisions of this Act applicable to orders shall be 7 USC 2910. applicable to amendments to orders. PRODUCER REFUND

SEC. 12. Notwithstanding any other provisions of this Act, any 7 USC 2911. producer against whose cattle any assessment is made and collected from him under authority of this Act and who is not in favor of supporting the programs as provided for herein shall have the right to demand and receive from the Beef Board a refund of such assessment: Provided, That such demand shall be made in accordance with regulations on a form and within a time period prescribed by the Board and approved by the Secretary but in no event more than sixty days ^^ after the end of the month in which the sale or slaughter of said cattle occurred and upon submission of proof satisfactory to the Board that the producer paid the assessment for which refund is sought, and any such refund shall be made within sixty days after demand is received therefor: Provided, however, That no producer shall claim or receive a refund of any portion of an assessment which he collected from other producers. PETITION AND REVIEW

SEC. 13. (a) Any person subject to any order may file a written 7 USC 2912. petition with the Secretary, stating that any such order or any provision of such order or any obligation imposed in connection therewith is not in accordance with law and praying for a modification thereof or to be exempted therefrom. He shall thereupon be given an oppor- Hearing, tunity for a hearing upon such petition, in accordance with regulations made by the Secretary. After such hearing, the Secretary shall make a ruling upon the prayer of such petition which shall be final, if in accordance with law. (d) The district courts of the United States in any district in which such person is an inhabitant, or has his principal place of business, are hereby vested with jurisdiction to review such ruling, provided a complaint for that purpose is filed within twenty days from the date

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 90 STAT. 536

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PUBLIC LAW 94-294^MAY 28, 1976 of the entry of such ruling. Service of process in such proceedings may be had upon the Secretary by delivering to him a copy of the complaint. If the court determmes that such ruling is not in accordance with law, it shall remand such proceedings to the Secretary with directions either (1) to make such ruling as the court shall determine to be in accordance with the law, or (2) to take such further proceedings as, in its opinion, the law requires. The pendency of proceedings instituted pursuant to subsection (a) of this section shall not impede, hinder, or delay the United States or the Secretary from obtaming relief pursuant to section 14(a) of this Act. /

7 USC 2913.

Penalty.

, 1 i.V

ENFORCEMENT

SEC. 14. (a) The several district courts of the United States are vested with jurisdiction specifically to enforce, and to prevent and restrain any person from violating any order or regulation made or issued pursuant to this Act. Any civil action authorized to be brought under this Act shall be referred to the Attorney General for appropriate action: Provided, That nothing in this Act shall be construed as requiring the Secretary to refer to the Attorney General minor violations of this Act whenever he believes that the administration and enforcement of the program would be adequately served by suitable written notice or warning to any person committing such violation. (b) Any person who willfully violates any provision of any order issued by the Secretary under this Act, or who willfully fails or refuses to collect or remit any assessment duly required of him thereunder, shall be liable to a penalty of not more than $1,000 for each such violation which shall accrue to the United States and may be recovered in a civil suit brought by the United States: Provided, That subsections (a) and (b) of this section shall be in addition to, and not exclusive of, the remedies provided now or hereafter existing at law or in ^uity. CERTIFICATION or ORGANIZATIONS

7 USC 2914.

Report, submittal to Secretary.

SEC. 15. The eligibility of any organization to represent producers of any designated geographic area of the United States to request the issuance of an order under section 5, and to participate in the making of nominations under section 8(b) shall be certified by the Secretary. Certification shall be based, in addition to other available information, upon a factual report submitted by the organization which shall contain information deemed relevant and specified by the Secretary for the making of such determination, including, but not limited to, the following: (a) geographic territory covered by the organization's active membership, (b) nature and size of the organization's active membership, proportion of total of such active membership accounted for by producers of cattle, and the volume of cattle produced by the organization's active membership in each such State, (c) the extent to which the cattle producer membership of such organization is represented in setting the organization's policies, (d) evidence of stability and permanency of the organization, (e) sources from which the organization's operating funds are derived, (f) functions of the organization, and (g) the organization's ability and willingness to further the aims and objectives of this Act:

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90 STAT. 537

Provided, however, That the primary consideration in determining the eligibility of an organization shall be whether its producer membership consists of a substantial number of producers who produce a substantial volume of cattle subject to the provisions of this Act. The Secretary shall certify any organization which he finds to be eligible under this section and his determination as to eligibility shall be finaL Where more than one organization is certified in any geographic area, such organizations may caucus to determine the area's nominations under section 8(b). STATE BEEF BOARDS

SEC. 16. Nothing in this Act shall be construed to preempt or inter- 7 USC 2915. fere with the workings of any beef board, beef council, or other beef promotion entity organized and operating within and by authority of any of the several States. REGULATIONS

SEC. 17. The Secretary is authorized to issue regulations with the 7 USC 2916. force and effect of law as may be necessary to carry out the provisions of this Act and the powers vested in him by this Act. INVESTIGATIONS: POWER TO SUBPENA AND TAKE OATHS AND AFFIRMATIONS: AID OF COURTS

SEC. 18. The Secretary may make such investigation as he deems ^ USC 2917. necessary for the effective carrying out of his responsibilities under this Act or to determine whether a producer or slaughterer of cattle or any other person has engaged or is about to engage in any acts or practice which constitute or will constitute a violation of any provisions of this Act, or of any order, or rule or regulation issued under this Act. For the purpose of such investigation, the Secretary is empowered to administer oaths and affirmations, subpena witnesses, compel their attendance, take evidence, and require the production of any books, papers, and documents which are relevant to the inquiry. Such attendance of witnesses and the production of any such records may be required from any place in the United States. In case of contumacy by, or refusal to obey a subpena to, any person, including a producer, the Secretary may invoke the aid of any court of the United States within the jurisdiction of which such investigation or proceeding is carried on, or where such person resides or carries on business, in requiring the attendance and testimony of witnesses and the production of books, papers, and documents; and such court may issue an order requiring such person to appear before the Secretary, there to produce records, if so ordered, or to give testimony touching the matter under investigation. Any failure to obey such order of the Penalty, court may be punished by such court as a contempt thereof. All process in any such case may be served in the judicial district whereof such person is an inhabitant or wherever he may be found. SEPARABILITY

SEC. 19. If any provision of this Act or the application thereof to 7 USC 2901 note, any person or circumstances is held invalid, the validity of the remainder of the Act and of the application of such provision to other persons and circumstances shall not be affected thereby.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/588

 90 STAT. 538

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PUBLIC LAW 94-294—MAY 28, 1976 AUTHORIZATION

7 USC 2918.

SEC. 20. There is hereby authorized to be appropriated out of any money in the Treasury not otherwise appropriated such funds as are necessary to carry out the provisions of this Act. The funds so appropriated shall not be available for payment of the expenses or expenditures of the Beef Board in administering any provisions of any order issued pursuant to the terms of this Act. EFFECTIVE DATE

7 USC 2901 note.

SEC. 21. This Act shall take effect upon enactment. Approved May 28, 1976.

LEGISLATIVE HISTORY: HOUSE REPORTS: No. 94-452 (Comm. on Agriculture) and Nos. 94-708 and 94-1044 (Comm. of Conference). SENATE REPORT No. 94-463 (Comm. on Agriculture and Forestry). CONGRESSIONAL RECORD: Vol. 121 (1975): Oct. 2, considered and passed House. Dec. 1, 2, considered and passed Senate, amended. Vol. 122 (1976): May 3, House agreed to conference report. May 12, Senate agreed to conference report.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/589

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 539

Public Law 94-295 94th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes.

May 28. 1976 [S. 510]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Medical Device SHORT TITLE AND TABLE OF CONTENTS

Amendments of 1976. 21 USC 301 note.

1. (a) This Act may be cited as the "Medical Device Amendments of 1976". (b) Whenever in this Act (other than in section 3(a)(1)(B)) an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. 21 USC 301. SECTION

TABLE OF CONTENTS Sec. 1. Short title and table of contents. Sec. 2. Regulation of medical devices. "Sec. 513. C'assitlcation of devices intended for human use. " (a) Device classes. "(b) Classification; classification panels. "(c) Classification panel organization and operation. " (d) Classification. " (e) Classification changes. "(f) Initial classification of certain devices. "(g) Information. " (h) Definitions. "Sec. 514. Performance standards. " (a) Provisions of standards. "(b) Initiation of a proceeding for a performance standard. "(c) Invitation for standards. " (d) Acceptance of certain existing standards. " (e) Acceptance of offer to develop standard. "(f) Development of standard by Secretary after publication . of subsection (c) notice. "(g) Establishment of a standard. "Sec. 515. Premarket approval. " (a) General requirement. "(b) Regulation to require premarket approval. "(c) Application for premarket approval. " (d) Action on an application for premarket approval. " (e) Withdrawal of approval of application. "(f) Product development protocol. "(g) Revievp. " (h) Service of orders. "Sec. 516. Banned devices. " (a) General rule. " (b) Special effective date. "Sec. 517. Judicial review. " (a) Application of section. "(b) Additional data, views, and arguments. "(c) Standard for review. " (d) Finality of judgments. " (e) Other remedies. "(f) Statement of reasons.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/590

 90 STAT. 540

PUBLIC LAW 94-295—MAY 28, 1976 TABLE OF CONTENTS—Continued

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Sec. 2. Regulation of medical devices.—Continued "Sec. 518. Notification and other remedies., " (a) Notification. •"(b) Repair, replacement, or refund. " (c) Reimbursement. " (d) Effect on other liability. -r ! "Sec. 519. Records and reports on devices. ? " (a) General rule. " (b) Persons exempt. "Sec. 520. General provisions respecting control of devices Intended for human use. " (a) General rule. ' ^' > " (b) Custom devices. "(c) Trade secrets. . . " (d) Notices and findings. " (e) Restricted devices. "(f) Good manufacturing practice requirements. " (g) Exemption for devices for investigational use. " (h) Release of safety and effectiveness information, " (i) Proceedings of advisory panels and committees. " (j) Traceability requirements. " (k) Research and development. "(1) Transitional provisions for devices considered as new drugs or antibiotic drugs. "Sec. 521. State and local requirements respecting devices. " (a) General rule. "(b) Exempt requirements.". Sec. 3. Conforming amendments. (a) Amendments to section 201. (b) Amendments to section 301. (c) Amendments to section 304. (d) Amendments to section 501. (e) Amendments to section 502. (f) Amendments to section 801. Sec. 4. Registration of device manufacturers. Sec. 5. Device established and oflScial names. Sec. 6. Inspections relating to devices. Sec. 7. Administrative restraint. . i | N. ' Sec. 8. Confidential information; presumption. Sec. 9. Color additives. Sec. 10. Assistance for small manufacturers of devices. REGULATION OT MEDICAL DEVICES

SEC. 2. Chapter V is amended by adding after section 512 the following new sections: "CLASSIFICATION' or DEVICES INTENDED FOR HUMAN USE

"Device Classes 21 USC 360c.

«SEC. 513. (a)(1) There are established the following classes of devices intended for human use: " (A) CLASS I, GENERAL CONTROLS.—

21 USC 351,352, 360. w *?L.^qfik 562, 564, 565., ^

" (i) A device for which the controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 or any combination of such sections are sufficient to provide reasonable assurance ®^ safety and effectiveness of the device. «^jj^ ^ device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish a performance standard to provide such assurance, but because it— " (I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is

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Page:United States Statutes at Large Volume 90 Part 1.djvu/591

 PUBLIC LAW 94-295~MAY 28, 1976 of substantial importance in preventing impairment of human health, and " (II) does not present a potential unreasonable risk of illness or injury, is to be regulated by the controls referred to in clause (i). "(B) CLASS II, PERFORMANCE STANDARDS.—A device which cannot be classified as a class I device because the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, for which there is sufficient information to establish a performance standard to provide such assurance, and for which it is therefore necessary to establish for the device a performance standard under section 514 to provide reasonable assurance of its safety and effectiveness. "(C) CLASS III, PREMARKET APPROVAL.—A device which because— "(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 are sufficient to provide reasonable assurance of the safety and effectiveness of the device and (II) cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness, and " ( i i)(I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or " ( II) presents a potential unreasonable risk of illness or injury, is to be subject, in accordance with section 515, to premarket approval to provide reasonable assurance of its safety and effectiveness. If there is not sufficient information to establish a performance standard for a device to provide reasonable assurance of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain such information. "(2) For purposes of this section and sections 514 and 515, the safety and effectiveness of a device are to be determined— "(A) with respect to the persons for whose use the device is represented or intended, "(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and "(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. "(3)(A) Except as authorized by subparagraph (B), the effectiveness of a device is, for purposes of this section and sections 514 and 515, to be determined, in accordance with regulations promulgated by the Secretary, on the basis of well-controlled investigations, including clinical investigations where appropriate, by experts qualified by training and experience to evaluate the effectiveness of the device, from which investigations it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device.

90 STAT. 541

21 USC 351,352, 360. ^^l*'?L ^c2'c * ' ' Post, p. 546.

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Page:United States Statutes at Large Volume 90 Part 1.djvu/592

 90 STAT. 542

Post, pp. 546, 552.

PUBLIC LAW 94-295—MAY 28, 1976 "(B) If the Secretary determines that there exists valid scientij&c evidence (other than evidence derived from investigations described in subparagraph (A)) — " (i) which is sufficient to determine the effectiveness of a device, and "(ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device, then, for purposes of this section and sections 514 and 515, the Secretary may authorize the effectiveness of the device to be determined on the basis of such evidence. "Classification; Classification Panels

"(b)(1) For purposes of— "(A) determining which devices intended for human use should be subject to the requirements of general controls, performance standards, or premarket approval, and "(B) providing notice to the manufacturers and importers of such devices to enable them to prepare for the application of such requirements to devices manufactured or imported by them, the Secretary shall classify all such devices (other than devices classified by subsection (f)) into the classes established by subsection (a). Panels of experts. For the purpose of securing recommendations with respect to the Establishment. classification of devices, the Secretary shall establish panels of experts or use panels of experts established before the date of the enactment of this section, or both. Section 14 of the Federal Advisory Commit5 USC app. I. tee Act shall not apply to the duration of a panel established under this paragraph. "(2) The Secretary shall appoint to each panel established under paragraph (1) persons who are qualified by training and experience ???; to evaluate the safety and effectiveness of the devices to be referred to the panel and who, to the extent feasible, possess skill in the use of, or experience in the development, manufacture, or utilization of, such devices. The Secretary shall make appointments to each panel so that each panel shall consist of members with adequately diversified expertise in such fields as clinical and administrative medicine, engineering, biological and physical sciences, and other related professions. In addition, each panel shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in the administration of this Act may be a member of any panel. The Secretary shall designate one of the members of each panel to serve as chairman thereof. " (3) Panel members (other than officers or employees of the United States), while attending meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, but not at rates exceeding the daily equivalent of the rate in effect for grade GS-18 of the General Sched5 USC 5332 note, ule, for each day so engaged, including traveltime; and while so serving away from their homes or regular places of business each member may be allowed travel expenses (including per diem in lieu of subsistence) as authorized by section 5703(b) of title 5, United States Code, for persons in the Government service employed intermittently.

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 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 543

"(4) The Secretary shall furnish each panel with adequate clerical and other necessary assistance. "Classification Panel Organization and Operation "(c)(1) The Secretary shall organize the panels according to the various fields of clinical medicine and fundamental sciences in which devices intended for human use are used. The Secretary shall refer a device to be classified under this section to an appropriate panel established or authorized to be used under subsection (b) for its review and for its recommendation respecting the classification of the device. The Secretary shall by regulation prescribe the procedure to be followed by the panels in making their reviews and recommendations. In making their reviews of devices, the panels, to the maximum extent practicable, shall provide an opportunity for interested persons to submit data and views on the classification of the devices. "(2)(A) Upon completion of a panel's review of a device referred to it under paragraph (1), the panel shall, subject to subparagraphs (B) and (C), submit to the Secretary'^ its recommendation for the classification of the device. Any such recommendation shall (i) contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and ( III) an identification of the risks to health (if any) presented by the device with respect to which the recommendation is made, and (ii) to the extent practicable, include a recommendation for the assignment of a priority for the application of the requirements of section 514 or 515 to a device recommended to be classified in class II or class III. "(B) A recommendation of a panel for the classification of a device in class I shall include a recommendation as to whether the device should be exempted from the requirements of section 510, 519, or 520(f). "(C) In the case of a device which has been referred under paragraph (1) to a panel, and which— "(i) is intended to be implanted in the human body or is purported or represented to be for a use in supporting or sustaining human life, and " ( i i)(I) has been introduced or delivered for introduction into interstate commerce for commercial distribution before the date of enactment of this section, or " ( II) is within a type of device which was so introduced or delivered before such date and is substantially equivalent to another device within that type, such panel shall reconmiend to the Secretary that the device be classified in class III unless the panel determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. If a panel does not recommend that sue]I a device be classified in class III, it shall in its recommendation to the Secretary for the classification of the device set forth the reasons for not recommending classification of the device in such class. "(3) The panels shall submit to the Secretary within one year of the date funds are first appropriated for the implementation of this section their recommendations respecting all devices of a type introduced or delivered for introduction into interstate commerce for commercial distribution before the date of the enactment of this section.

89-194 0 _ 7 8 — n t 1

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Post, pp. 546, 552.

21 USC 360. ^^^ PP" ^ ^ '

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Page:United States Statutes at Large Volume 90 Part 1.djvu/594

 90 STAT. 544

PUBLIC LAW 94-295—MAY 28, 1976 "Classification

Publication in "(d)(1) Upon receipt of a recommendation from a panel respecting Federal Register. ^ device, the Secretary shall publish in the Federal Eegister the panel's recommendation and a proposed regulation classifying such device and shall provide interested persons an opportunity to submit comments on such recommendation and the proposed regulation. After reviewing such comments, the Secretary shall, subject to paragraph (2), by regulation classify such device. "(2)(A) A regulation under paragraph (1) classifying a device in class I shall prescribe which, if any, of the requirements of section 21 USC 360. 510, 519, or 520(f) shall not apply to the device. A regulation which Post, pp. 564, makes a requirement of section 510, 519, or 520(f) inapplicable to a 565. device shall be accompanied by a statement of the reasons of the Secretary for making such requirement inapplicable. "(B) A device described in subsection (c)(2)(C) shall be classified in class III unless the Secretary determines that classification of the device in such class is not necessary to provide reasonable assurance ^ of its safety and effectiveness. A proposed regulation under paragraph (1) classifying such a device in a class other than class III shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for not classifying such device in such class and an identification of the risks to health (if any) presented by such device. "(3) In the case of devices classified in class II and devices classiPost, p. 552. fied under this subsection in class III and described in section 515(b) (1) the Secretary may establish priorities which, in his discretion, shall Post, p. 546. be used in applying sections 514 and 515, as appropriate, to such devices. "Classification Changes Regulation.

"(e) Based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of an interested person, by regulation (1) change such device's classification, and (2) revoke, because of the change in classification, any regulation or requirement in Publication in effect under section 514 or 515 with respect to such device. In the Federal Register, promulgation of such a regulation respecting a device's classification, the Secretary may secure from the panel to which the device was last referred pursuant to subsection (c) a recommendation respecting the proposed change in the device's classification and shall publish in the Federal Register any recommendation submitted to the Secretary by the panel respecting such change. A regulation under this subsection chan^ng the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 514 for such device. "Initial Classification of Certain Devices "(f)(1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution before the date of the enactment of this section is classified in class III unless— "(A) the device— "(i) is within a type of device (I) which was introduced or delivered for introduction into interstate commerce for commercial distribution before such date and which is to be classified pursuant to subsection (b), or (II) which was not so

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Page:United States Statutes at Large Volume 90 Part 1.djvu/595

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 545

introduced or delivered before such date and has been classified in class I or II, and "(ii) is substantially equivalent to another device within such type, or "(B) the Secretary in response to a petition submitted under paragraph (2) has classified such device in class I or II. A device classified in class III under this paragraph shall be classified in that class until the effective date of an order of the Secretary under paragraph (2) classifying the device in class I or II. "(2)(A) The manufacturer or importer of a device classified under Petition. paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the device in class I or class II. Within thirty days of the filing of such Notification. a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the petition. "(B)(i) Upon determining that a petition does not contain any deficiency which prevents the Secretary from making a decision on the petition, the Secretary shall refer the petition to an appropriate panel established or authorized to be used under subsection (b). A panel to which such a petition has been referred shall not later than ninety days after the referral of the petition make a recommendation to the Secretary respecting approval or denial of the petition. Any such recommendation shall contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and ( III) an identification of the risks to health (if any) presented by the device with respect to which the petition was filed. In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be for a use in supporting or sustaining human life, the panel shall recommend that the petition be denied unless the panel determines that the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. If the panel recommends that such petition be approved, it shall in its recommendation to the Secretary set forth its reasons for such recommendation. "(ii) The requirements of paragraphs (1) and (2) of subsection (c) (relating to opportunities for submission of data and views and recommendations respecting priorities and exemptions from sections 510, 519, and 520(f)) shall apply with respect to consideration by 21 USC 360. Post, pp. 564s panels of petitions submitted under subparagraph (A). "(C)(i) Within ninety days from the date the Secretary receives 565. the recommendation of a panel respecting a petition (but not later than 210 days after the filing of such petition) the Secretary shall by order deny or approve the petition. If the Secretary approves the petition, the Secretary shall order the classification of the device into class I or class II in accordance with the criteria prescribed by subsection (a^ (1)(A) or (a)(1)(B). In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall deny the petition unless the Secretary determines that the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. An order approving such petition shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for approving the petition and an identification of the risks to health (if any) presented by the device to which such order applies, "(ii) The requirements of paragraphs (1) and (2)(A) of subsec-

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