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Reports.
21 USC 333 note.

the validity, amount, and appropriateness of such penalty shall not
be subject to review.".
(b) EFFECTIVE DATE OF APPLICATION TO DEVICE USER FACILITIES. —

(1) The Secretary of Health and Human Services shall conduct a study to determine whether there has been substantial compliance with the requirements of section 519(b) of the Federal Food, Drug, and Cosmetic Act by device user facilities (as defined in section 519(b5)(A) of such Act). The Secretary shall report the results of the study to the Congress after the expiration of 45 months after the date of the enactment of this Act.

(2)(A) If upon the expiration of 48 months after the date of the enactment of this Act the Secretary has not made the report required by paragraph (1), section 303(f) of the Federal Food, Drug, and Cosmetic Act, as added by the amendment made by subsection (a), shall take effect with respect to device user facilities (as defined in section 519(b)(5XA) of such Act).

(B) If in the report under paragraph (1) the Secretary reports that there has been substantial compliance with the requirements of such section 519(b) by a type of device user facility and if the Secretary does not make a determination under subparagraph (C) with respect to such type of facility, such section 303(f) shall not take effect with respect to such type of facility.

(C) If the Secretary determines in the report under paragraph (1) that there is not substantial compliance with the requirements of such section 519(b) by a type of device user facility or if the Secretary makes such a determination after making the report under paragraph (1), such section 303(f) shall take effect with respect to such type of facility upon the effective date of

the report.
SEC. 18. MISCELLANEOUS.

(a) SECTION 513(f).-Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is amended in subparagraph (B)(i), by striking out “the Secretary shall” and inserting in lieu thereof "the Secretary may for good cause shown”.

(b) SECTION 514.-Section 514(b) (21 U.S.C. 360d(b)(4)(B)) (as so redesignated) is amended

(1) in paragraph (3)(B) (as so redesignated), by striking out“, after affording all interested persons an opportunity for an informal hearing,”, and

(2) in clause (ii) of paragraph (4)(A) (as so redesignated), by striking out "unless” and all that follows in that clause and inserting in lieu thereof the following: "which demonstrates good cause for referral and which is made before the expiration of the period for submission of comments on such proposed

regulation refer such proposed regulation,”. (c) SECTION 515.-Section 515(c)2) (21 U.S.C. 360e(c)(2)) is amended

(X2) by striking, out “paragraph (1), the Secretary shall refer such application” and inserting in lieu thereof “paragraph (1), the Secretary

“(A) may on the Secretary's own initiative refer such application, or

“(B) shall, upon the request of an applicant unless the Secretary finds that the information in the application which would be reviewed by a panel substantially duplicates information which has previously been reviewed by a panel appointed

under section 513, refer such application".

(d) SECTION 516.-Section 516(a) (21 U.S.C. 360f(a)) is amended (1) by striking out "and after consultation with the appropriate panel or panels under section 513", and (2) by striking out the last sentence.

(e) SECTION 520(f).-Section 520(f)(1)(A) (21 U.S.C. 360j(f)(1)(A) is amended by inserting “pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device),” after "manufacture,"

(f) SECTION 520(1).-Section 520(1)(2) (21 U.S.C. 360j(1)(2)) is amended by striking out "and after affording the petitioner an opportunity for an informal hearing". SEC. 19. ELECTRONIC PRODUCTS. (a) IN GENERAL.

(1) Subpart 3 of part F of title III of the Public Health Service Act is amended as follows:

(A) The heading for the subpart is amended to read as follows:

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"SUBCHAPTER C-ELECTRONIC PRODUCT RADIATION CONTROL".

(B) The subpart is amended by striking out “subpart" 42 USC each place it occurs and inserting in lieu thereof "sub- 2636-263n.

chapter"
(2)(A) Section 356 of such Act is amended-

42 USC 263d.
(i) by striking out "358" each place it occurs and inserting
in lieu thereof 534", and

(ii) by striking out "sections 3648 and 3709 of the Revised Statutes of the United States (31 U.S.C. 529, 41 U.S.C. 5)" and inserting in lieu thereof "section 3324 of title 31, United States Code, and section 3709 of the Revised Stat

utes of the United States (41 U.S.C. 5)". (B) Section 358(a)(1)(E) of such Act is amended by striking out "355" and inserting in lieu thereof “531”. (C) Section 359 of such Act is amended

42 USC 263g. (i) by striking out "358” each place it occurs and inserting in lieu thereof “534”, and

(ii) by striking out “360A” each place it occurs and inserting in lieu thereof “537”. (D) Section 360 of such Act is amended by striking out “358" 42 USC 263h. each place it occurs and inserting in lieu thereof “534”. (E) Section 360A of such Act is amended

42 USC 263i.
(i) by striking out "358" and inserting in lieu thereof
"534", and

(ii) by striking out "359" each place it occurs and insert-
ing in lieu thereof “535”.
(F) Section 360B of such Act is amended-

42 USC 263j.
(i) by striking out “358” each place it occurs and inserting
in lieu thereof “534”,

(ii) by striking out "359" each place it occurs and insert-
ing in lieu thereof “535”, and

(iii) by striking out “360A” each place it occurs and
inserting in lieu thereof “537.
(G) Section 360C of such Act is amended

42 USC 263k.

42 USC 263n.

Repeal.
42 USC 263b.
42 USC 263c-
263n.

42 USC 263b-263n.

(i) by striking out "358" and inserting in lieu thereof "534",

(ii) by striking out “360B” each place it occurs and inserting in lieu thereof “538", and

(iii) by striking out “360F” and inserting in lieu thereof "542". (H) Section 360F of such Act is amended by striking out "358" and inserting in lieu thereof “534".

(3) Section 354 of such Act is repealed and sections 355 through 360F of such Act are redesignated as sections 531 through 542, respectively.

(4) Subpart 3 of part of title III of the Public Health Service Act, as amended by paragraphs (1) and (2) of this subsection, is transferred to chapter V of the Federal Food, Drug, and Cosmetic Act and is placed after section 528 and sections 354 through 360F of such subpart are redesignated as sections 530 through 542 of the Federal Food, Drug, and Cosmetic Act,

respectively. (b) CONFORMING AMENDMENT.—The heading for part F of title III of the Public Health Service Act is amended by striking out "AND CONTROL OF RADIATION".

(c) CONSTRUCTION.—The transfer of subpart 3 of part F of title III of the Public Health Service Act to the Federal Food, Drug, and Cosmetic Act does not change the application of the requirements of such subpart and such Act to electronic products which were in effect on the date of the enactment of this Act.

21 USC 360gg-360ss.

42 USC prec.
262.
21 USC 360hh.

Approved November 28, 1990.

LEGISLATIVE HISTORY-H.R. 3095 (S. 3006):
HOUSE REPORTS: No. 101-808 (Comm. on Energy and Commerce) and No. 101-959

(Comm. of Conference).
SENATE REPORTS: No. 101-513

accompanying S. 3006 (Comm. on Labor and Human

Resources).
CONGRESSIONAL RECORD, Vol. 136 (1990):

Oct. 10, considered and passed House.
Oct. 12, H.R. 3095 considered and passed Senate, amended, in lieu of S. 3006.
Oct. 26, House agreed to conference report.
Oct. 27, Senate agreed to conference report.

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Nov. 28, 1990 [H.R. 3703]

To authorize the Rumsey Indian Rancheria to convey a certain parcel of land. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

TITLE I-RUMSEY INDIAN RANCHERIA

SECTION 101. FINDINGS.
The Congress finds that-

(1) the Rumsey Indian Rancheria, a part of the Wintun Tribe California. of Indians, is a federally recognized Indian tribe, located in Rumsey, California, where eighty-three and thirty-nine hundredths acres of land are held in trust for the Rancheria by the United States;

(2) in February, 1987, fee simple title to property located at lot 23, Sierra Meadows subdivision, unit 5A, Washoe County, Nevada, commonly known as 978 O'Callahan Street, Sparks, Nevada, was transferred to the Rancheria which it presently holds under the name Wintun Indian Tribe;

(3) such property is located approximately one hundred twenty-five miles from the Rancheria trust land base in California, and ownership of such land, which is in a residential area, provides no significant benefit for the tribal members;

(4) the most beneficial use of such land is to sell it at its present market value and to utilize the proceeds for the improvement of the tribe's economic and social welfare; and

(5) section 2116 of the Revised Statutes (25 U.S.C. 177) prohibits the conveyance of any lands owned by Indian tribes

without the consent of Congress. SEC. 102. CONVEYANCE OF LAND.

(a) AUTHORITY.-Notwithstanding section 2116 of the Revised Stat- Nevada. utes (25 U.S.C. 177), Rumsey Indian Rancheria is authorized to convey that land known as lot 23, Sierra Meadows subdivision, unit 5A, Washoe County, Nevada, commonly known as 978 O'Callahan Street, Sparks, Nevada, to any bona fide purchaser for value.

(b) PROCEEDS.-Proceeds from the conveyance of land pursuant to subsection (a) may be used only for the economic development and social welfare of the Rumsey Indian Rancheria.

TITLE II-MILLE LACS INDIAN

RESERVATION LEASE

SEC. 201. MILLE LACS INDIAN RESERVATION LEASE TO MINNESOTA

STATE HISTORICAL SOCIETY. The first section of the Act of August 9, 1955 (25 U.S.C. 415), is amended by inserting "the Mille Lacs Indian Reservation with respect to a lease between an entity established by the Mille Lacs Band of Chippewa Indians and the Minnesota Historical Society," after "the Navajo Reservation,”.

National Indian
Forest Resources
Management
Act.

TITLE III-INDIAN FOREST AND

WOODLANDS

25 USC 3101 note.

25 USC 3101.

SEC. 301. SHORT TITLE.

This title may be cited as the “National Indian Forest Resources
Management Act”.
SEC. 302. FINDINGS.
The Congress finds and declares that-

(1) the forest lands of Indians are among their most valuable resources and Indian forest lands

(A) encompass more than 15,990,000 acres, including more than 5,700,000 acres of commercial forest land and 8,700,000 acres of woodland,

(B) are a perpetually renewable and manageable resource,

(C) provide economic benefits, including income, employment, and subsistence, and

(D) provide natural benefits, including ecological, cultural, and esthetic values; (2) the United States has a trust responsibility toward Indian forest lands;

(3) existing Federal laws do not sufficiently assure the adequate and necessary trust management of Indian forest lands;

(4) the Federal investment in, and the management of, Indian forest land is significantly below the level of investment in, and management of, National Forest Service forest land, Bureau of Land Management forest land, or private forest land;

(5) tribal governments make substantial contributions to the overall management of Indian forest land; and

(6) there is a serious threat to Indian forest lands arising from trespass and unauthorized harvesting of Indian forest land

resources.
SEC. 303. PURPOSES.
The purposes of this title are to-

(1) allow the Secretary of the Interior to take part in the management of Indian forest lands, with the participation of the lands' beneficial owners, in a manner consistent with the Secretary's trust responsibility and with the objectives of the beneficial owners;

(2) clarify the authority of the Secretary to make deductions from the proceeds of sale of Indian forest products, assure the

25 USC 3102.

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