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16 USC la-10.

16 USC la-11.

States House of Representatives and the Committee on Energy and Natural Resources and the Committee on Appropriations of the United States Senate on the findings of such review, together with such recommendations as the Secretary determines necessary. The first report shall be submitted no later than 3 years after the date of enactment of this Act.

Sec. 1214. In conducting and preparing the report referred to in section 1, the Secretary shall consult with appropriate officials of affected Federal, State and local agencies, together with national, regional, and local organizations, including but not limited to holding such public hearings as the Secretary determines to be appropriate to provide a full opportunity for public comment. Sec. 1215. The report shall contain

(a) A comprehensive listing of all authorized but unacquired lands within the exterior boundaries of each unit of the National Park System as of the date of enactment.

(b) A priority listing of all such unacquired parcels by individual park unit and for the National Park System as a whole. The list shall describe the acreage and ownership of each parcel, the estimated cost of acquisition for each parcel (subject to any statutory acquisition limitations for such lands), and the basis for such estimate.

(c) An analysis and evaluation of the current and future needs of each unit of the National Park System for resource management, interpretation, construction, operation and maintenance, personnel, housing, together with an estimate of the costs

thereof. SEC. 1216. Within one year after the date of enactment, the Secretary shall develop criteria to evaluate any proposed changes to the existing boundaries of individual park units including

(a) analysis of whether or not the existing boundary provides for the adequate protection and preservation of the natural, historic, cultural, scenic and recreational resources integral to the unit;

(b) an evaluation of each parcel proposed for addition or deletion to the unit based on the analysis under paragraph (1);

(c) an assessment of the impact of potential boundary adjustments taking into consideration the factors in paragraph (C) as well as the effect of the adjustments on the local communities

and surrounding area. SEC. 1217. In proposing any boundary change after the date of enactment of this section, the Secretary shall

(a) consult with affected agencies of State and local governments surrounding communities, affected landowners and private national, regional, and local organizations;

(b) apply the criteria developed pursuant to section 1216 and accompany this proposal with a statement reflecting the results of the application of such criteria;

(c) include with such proposal an estimate of the cost for acquisition of any parcels proposed for acquisition together with the basis for the estimate and a statement on the relative priority for the acquisition of each parcel within the priorities for acquisition of other lands for such unit and for the National Park System.

16 USC la-12.

16 USC la-13.

TITLE XIII

Clarks Fork

Wild and Scenic SEC. 1301. This Act may be cited as the "Clarks Fork Wild and

River

Designation Act Scenic River Designation Act of 1990”.

of 1990.

16 USC 1271 SEC. 1302. DESIGNATION OF RIVER.

note. Section 3(a) of the Wild and Scenic Rivers Act (16 U.S.C. 1274(a)), as amended, is further amended by adding at the end the following:

"( ) CLARKS FORK, WYOMING.-(A) The twenty and five-tenthsmile segment from the west boundary of section 3, township 56 north, range 106 west at the Crandall Creek Bridge downstream to the north boundary of section 13, township 56 north, range 104 west at Clarks Fork Canyon; to be administered by the Secretary of Agriculture as a wild river. Notwithstanding subsection (b), the boundary of the segment shall include all land within four hundred and forty yards from the ordinary high water mark on both sides of the river. No land or interest in land may be acquired with respect to the segment without the consent of the owner thereof. For the Appropriation purposes of carrying out this paragraph, there is authorized to be authorization. appropriated $500,000 for development and $750,000 for the acquisition of land and interests therein.

"(B) Designation of a segment of the Clarks Fork by this paragraph as a component of the Wild and Scenic Rivers System shall not be utilized in any Federal proceeding, whether concerning a license, permit, right-of-way, or any other Federal action, as a reason or basis to prohibit the development or operation of any water impoundment, diversion facility, or hydroelectric power and transmission facility located entirely downstream from the segment of the river designated by this paragraph: Provided, That water from any development shall not intrude upon such segment. Congress finds that development of water impoundments, diversion facilities, and hydroelectric power and transmission facilities located entirely downstream from the segment of the river is not incompatible with its designation as a component of the Wild and Scenic Rivers System.

“(C) The Secretary of Agriculture is directed to apply for the quantification of the water right reserved by the inclusion of a portion of the Clarks Fork in the Wild and Scenic Rivers System in accordance with the procedural requirements of the laws of the State of Wyoming: Provided, That, notwithstanding any provision of the laws of the State of Wyoming otherwise applicable to the granting and exercise of water rights, the purposes for which the Clarks Fork is designated, as set forth in this Act and this paragraph, are declared to be beneficial uses and the priority date of such right shall be the date of enactment of this paragraph.

“(D) The comprehensive management plan developed under subsection (d) for the segment designated by this paragraph shall provide for all such measures as may be necessary in the control of fire, insects, and diseases to fully protect the values for which the segment is designated as a wild river."

Approved November 28, 1990.

LEGISLATIVE HISTORY-H.R. 2570 (See S. 3068):
HOUSE REPORTS: No. 101-405 (Comm. on Interior and Insular Affairs).
SENATE REPORTS: No. 101-359 (Comm. on Energy and Natural Resources).
CONGRESSIONAL RECORD, Vol. 136 (1990):

Feb. 28, considered and passed House.
Oct. 27, considered and passed Senate, amended. House concurred in Senate

amendment with an amendment. Senate concurred in House amendment.

[blocks in formation]

To amend the Federal Food, Drug, and Cosmetic Act to make improvements in the Nov. 28, 1990 regulation of medical devices, and for other purposes.

[H.R. 3095] Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

Safe Medical

Devices Act of SECTION 1. SHORT TITLE AND REFERENCE TO ACT.

1990. (a) SHORT TITLE.—This Act may be cited as the "Safe Medical Health care. Devices Act of 1990”.

21 USC 301 note. (b) REFERENCE.—Whenever in this Act (other than in section 19) an amendment or repeal is expressed in terms of an amendment to, or repeal of, 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. SEC. 2. USER REPORTS.

(a) REQUIREMENT.-Section 519 (21 U.S.C. 360i) is amended by redesignating subsection (b) as subsection (c) and by inserting after subsection (a) the following:

"User Reports

"(b)(1)(A) Whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that there is a probability that a device has caused or contributed to the death of a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the Secretary and, if the identity of the manufacturer is known, to the manufacturer of the device. In the case of deaths, the Secretary may by regulation prescribe a shorter period for the reporting of such information.

"(B) Whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that there is a probability that a device has caused or contributed to the serious illness of, or serious injury to, a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the manufacturer of the device or to the Secretary if the identity of the manufacturer is not known.

"(C) Each device user facility shall submit to the Secretary on a semi-annual basis a summary of the reports made under subparagraphs (A) and (B). Such summary shall be submitted on January 1 and July 1 of each year. The summary shall be in such form and contain such information from such reports as the Secretary may require and shall include

"(i) sufficient information to identify the facility which made the reports for which the summary is submitted,

"(ii) in the case of any product which was the subject of a report, the product name, serial number, and model number,

"(iii) the name and the address of the manufacturer of such device, and

"(iv) a brief description of the event reported to the manufac

turer. The Secretary may by regulation alter the frequency and timing of reports required by this subparagraph.

*(D) For purposes of subparagraphs (A), (B), and (C), a device user facility shall be treated as having received or otherwise become aware of information with respect to a device of that facility when medical personnel who are employed by or otherwise formally affiliated with the facility receive or otherwise become aware of information with respect to that device in the course of their duties.

“(2) The Secretary may not disclose the identity of a device user facility which makes a report under paragraph (1) except in connection with

"(A) an action brought to enforce section 301(q),

"(B) a communication to a manufacturer of a device which is the subject of a report under paragraph (1), or

"(C) a disclosure required under subsection (a). This paragraph does not prohibit the Secretary from disclosing the identity of a device user facility making a report under paragraph (1) or any information in such a report to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress. "Ž) No report made under paragraph (1) by

(A) a device user facility, "(B) an individual who is employed by or otherwise formally affiliated with such a facility, or

"(C) a physician who is not required to make such a report, shall be admissible into evidence or otherwise used in any civil action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report.

"(4) A report made under paragraph (1) does not affect any obligation of a manufacturer who receives the report to file a report as required under subsection (a). “(5) For purposes of this subsection:

(A) The term "device user facility' means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician's office. The Secretary may by regulation include an outpatient diagnostic facility which is not a physician's office in such term.

"(B) The terms 'serious illness' and 'serious injury' mean illness or injury, respectively, that

“(i) is life threatening,

"(ii) results in permanent impairment of a body function or permanent damage to a body structure, or

"(iii) necessitates immediate medical or surgical intervention to preclude permanent impairment of a body function

or permanent damage to a body structure.' (b) REGULATIONS. -The Secretary of Health and Human Services shall promulgate regulations to implement section 519(b) of the Federal Food, Drug, and Cosmetic Act, as added by the amendment made by subsection (a) (including a definition of the summary required by paragraph (1)(C) of such section) not later than 12 months after the date of enactment of this Act. In promulgating the

21 USC 360i note.

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