Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Notices 65813

3506 (c)(2)(A) of the PRA (44 U.S.C.

3506 (c)(2)(A)) requires Federal agencies

to provide a 60-day notice in the

Federal Register concerning each

proposed collection of information,

including each proposed reinstatement

of an existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Petition For Administrative

Reconsideration of Action—21 CFR

Part 10.33—(OMB Control Number

0910–0192)—Reinstatement

Section 10.33 (21 CFR 10.33), issued

under section 701(a) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 371(a)), sets forth the format

and procedures by which an interested

person may petition the Commissioner

of Food and Drugs (the Commissioner)

for reconsideration of an agency’s

action. A petition for reconsideration

must contain a full statement in a wellorganized format of the factual and legal

grounds upon which the petition relies.

The grounds must demonstrate that

relevant information and views

contained in the administrative record

were not previously or not adequately

considered by the Commissioner. Each

petition must be submitted no later than

30 days after the decision involved. The

Commissioner may, for good cause,

permit a petition to be filed after 30

days. An interested person who wishes

to rely on information or views not

included in the administrative record

shall submit them with a new petition

to modify the decision. FDA uses the

information provided to determine

whether to grant the petition for

reconsideration. Respondents to this

collection of information are individuals

of households, state or local

governments, not-for-profit institutions,

and businesses or other for-profit

institutions.

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

10.33(b) 7 1 7 100 700

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimate for this

collection of information is based on

agency records and experience over the

past 3 years. Agency personnel handling

the petitions for administrative

reconsideration of an action estimate

approximately seven requests being

received by the agency annually, each

requiring an average of 100 hours

preparation time.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32805 Filed 12–15–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0182]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Transmittal of Labels and Circulars,

Form FDA 2567’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 19, 1997

(62 FR 49244), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0039. The

approval expires on November 30, 2000.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32808 Filed 12–15–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Statement of Organization, Functions,

and Delegations of Authority

Part F, of the Statement of

Organization, Functions and

Delegations of Authority of the

Department of Health and Human

Services, Health Care Financing

Administration (HCFA), (49 Federal

Register 34247, dated September 6,

1984) is amended to include the

following delegation of authority from

the Secretary to the Administrator for

Title XXI of the Social Security Act.

The specific amendments to Part F are

described below:

I. Section F.30., Delegations of

Authority is amended by adding the

following paragraph: SS. The authority

vested in the Secretary under Title XXI

of the Security Act (42 U.S.C. 1397aa et

seq.).

Limitation: No State plan or

amendment shall be finally disapproved

without consultation and discussion by

the Administrator with the Secretary.

II. Section F.30., Delegations of

Authority, paragraph RR is revised to

include title XXI, the revised paragraph

reads as follows:
65814 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Notices

RR. The authority vested in the

Secretary or that may become vested in

the Secretary, and not otherwise

delegated, limited, or reserved, to

conduct studies and demonstration

projects, as directed by Congress, that

relate to the programs established by

Title XI of the Social Security Act (Act),

insofar as they relate to the mission of

the Health Care Financing

Administration (HCFA), and Titles

XVIII, XIX, and XXI. This delegation

encompasses the authority to approve

related program activities required by

the studies and demonstration projects

if such authority is or becomes vested in

the Secretary and is not otherwise

delegated, limited, or reserved. These

activities include, but are not limited to,

direct performance, entering into

contracts or cooperative agreements,

making grants, approving payments for

contracts, cooperative agreements, and

grants and approving authorized

waivers of compliance with certain

requirements of titles XI, XVIII, and XIX

and XXI of the Act when such actions

are for the purpose of conducting

studies and demonstration projects.

This delegation shall be exercised

under the Department’s existing

delegation of authority and policy on

regulations. In addition, I hereby ratify

and affirm any actions taken by the

Administrator or other HCFA officials

which, in effect, involved the exercise of

this authority prior to the effective date

of this delegation. This delegation is

effective immediately.

Dated: December 2, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–32747 Filed 12–15–97; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Cancer Institute Special

Emphasis Panel (SEP) meeting:

Name of SEP: Cancer Education Program,

Telephone Conference Call.

Date: December 18, 1997.

Time: 3:30 p.m. to Adjournment.

Place: National Cancer Institute, Executive

Plaza North, Room 611A, 6130 Executive

Boulevard, Bethesda, MD 20892.

Contact Person: Mary Bell, Ph.D., Scientific

Review Administrator, National Cancer

Institute, NIH, Executive Plaza North, Room

611A, 6130 Executive Boulevard, Bethesda,

MD 20892, Telephone: 301/496–7978.

Purpose/Agenda: To review, discuss and

evaluate grant applications.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

The meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.

Grant applications and the discussions could

reveal confidential trade secrets or

commercial property such as patentable

material and personal information

concerning individuals associated with the

proposals, the disclosure of which would

constitute a clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower,

93.399, Cancer Control.)

Dated: December 10, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–32745 Filed 12–15–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN RESOURCES

National Institutes of Health

Electric and Magnetic Fields Research

and Public Information; Dissemination

(EMFRAPID) Program; Environmental

Toxicology Program, Office of Special

Programs; National Institute of

Environmental Health Sciences,

National Institutes of Health

NOTICE: Second EMF Science Review

Symposium—EMFRAPID Program.

Background

The National Institute of

Environmental Health Sciences (NIEHS)

and the Department of Energy (DOE) are

coordinating the implementation of the

Electric and Magnetic Fields (EMF)

Research and Public Information

Dissemination (RAPID) Program.

EMFRAPID was established by the 1992

Energy Policy Act (Section 2118 for

Public Law 102–486) which was signed

in October 1992. This five-year effort is

designed to determine the potential

effect from exposure to 60 Hz electric

and magnetic fields on biological

systems, especially those produced by

the generation, transmission and use of

electric energy. DOE is responsible for

characterizing field exposures and for

mitigating exposures which may be

hazardous. The NIEHS is responsible for

the development and implementation of

a research program on the possible

human health effects of electric and

magnetic fields (EMF). The RAPID

Program requires the NIEHS to report on

the extent to which exposure to electric

and magnetic fields adversely affects

human health.

The NIEHS has three groups that

assist in managing and directing the

science portion of RAPID and who will

provide guidance on reporting on the

health effects of electric and magnetic

fields. The first, known as the

Interagency Agency Committee on

Electric and Magnetic Fields (IAC) is

composed of representatives from 10

federal agencies with responsibilities

related to electric and magnetic fields

(DOE, NIEHS, the Environmental

Protection Agency (EPA), the

Department of Defense (DOD), the

Occupational Safety and Health

Administration (OSHA), the National

Institute of Standards and Technology

(NIST), the Department of

Transportation (DOT), the Rural

Electrification Administration (REA),

the Department of the Interior (DOI),

and the Federal Energy Regulatory

Commission (FERC)). The IAC,

established by the President of the

United States, must also prepare a final

report for Congress.

The second is the National Electric

and Magnetic Field Advisory Committee

(NEMFAC). NEMFAC consists of

representatives from public interest

groups, organized labor, state

governments, academia, and industry.

This groups advises DOE and NIEHS on

the design and implementation of the

program. NEMFAC also provides

recommendations to the IAC.

Finally, the NIEHSA has an internal

EMF Steering Committee (SC) consisting

of senior scientists with broad

programmatic responsibilities and a

broad scientific perspective. The SC

manages all aspects of the EMFRAPID

Research Program at the NIEHS.

NIEHS Report on Human Health Effects

of EMF

The report development process

combines a critical evaluation of the

scientific literature with an assessment

of the strength of the evidence for

human health effects resulting from

EMF exposures. To accomplish the

initial part of this process, the NIEHS is

convening a series of open, public

symposia on science related to EMF

exposures and their biological effects for

these study areas: theoretical/in vitro

research findings, epidemiological

results, and in vivo/clinical laboratory

findings. The symposia (March 1997,

January 1998, and April 1998) provide