45426 Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Notices

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

For information concerning human

drug products: Audrey A. Thomas,

Center for Drug Evaluation and

Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

5625.

For information concerning human

licensed biological products: Marcel

E. Salive, Center for Biologics

Evaluation and Research (HFM–

220), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–827–3974.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled

‘‘Postmarketing Adverse Experience

Reporting for Human Drug and Licensed

Biological Products: Clarification of

What to Report.’’ FDA has undertaken a

major effort to clarify and revise its

regulations regarding pre- and

postmarketing safety reporting

requirements for human drug and

biological products. With regard to the

postmarketing safety reporting

regulations for human drug and licensed

biological products, the agency

published a proposed rule in the

Federal Register of October 27, 1994 (59

FR 54046), to amend these

requirements, as well as others, to

implement international standards, and

to facilitate the reporting of adverse

experiences. FDA is still considering

comments submitted in response to this

proposed rule and will be finalizing the

proposed amendments based on those

comments as well as on

recommendations developed by the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH)

and by the World Health Organization’s

Council for International Organizations

of Medical Sciences (CIOMS). In

addition, in response to the President’s

regulatory reinvention initiative, which

directed departments and agencies to

eliminate or modify regulations that are

outdated or otherwise in need of reform,

FDA recently published a final rule in

the Federal Register (62 FR 34166, June

25, 1997) that revokes the postmarketing

safety reporting requirement to submit

expedited increased frequency reports

for human drug and licensed biological

products.

At this time, the agency is considering

recommendations recently developed by

ICH and plans to propose additional

amendments to its postmarketing safety

reporting regulations. Throughout this

effort, the agency intends to develop

guidances for industry to provide

recommendations on how industry can

best fulfill the postmarketing safety

reporting requirements. FDA plans to

prepare a single consolidated guidance

document on this topic once the process

is concluded.

This guidance document: (1)

Describes the information that should be

obtained before an individual case of an

adverse experience should be

considered for submission to FDA in an

expedited or periodic report; (2) clarifies

how safety information from solicited

contacts with patients should be

handled; and (3) informs applicants and

licensed manufacturers that FDA will

entertain waiver requests for periodic

submission of individual case reports

for adverse experiences that are

determined to be nonserious and

labeled. The guidance for industry

should be used in conjunction with

CDER’s ‘‘Guideline for Postmarketing

Reporting of Adverse Drug Experiences’’

(March 1992) and CBER’s ‘‘Guideline for

Adverse Experience Reporting for

Licensed Biological Products’’ (October

1993).

This guidance document represents

the agency’s current thinking on

reporting of certain postmarketing

adverse experiences for human drug and

licensed biological products. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirement of the

applicable statute, regulations, or both.

Interested persons may, at any time,

submit written comments and requests

on the guidance document to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. The guidance document and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

An electronic version of this guidance

is also available on the Internet at http:/

/www.fda.gov/cder/guidance.htm or

http://www.fda.gov/cber/

guidelines.htm.

Dated: August 21, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22790 Filed 8–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA 901, 1–3]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Qualification

Application for Competitive Medical

Plan, Medicare Contract Application for

Federally Qualified Health Maintenance

Organization (HMO) and supporting

regulations 42 CFR 417.143, and

417.408; Form No.: HCFA–901, 1–3

OMB # 0938–0470; Use: Prepaid health

plans must meet certain regulatory

requirements which are captured in

these applications, before they are

considered a Federally qualified HMO

that is eligible for a Medicare § 1876

contract. Section 1876 of the Social

Security Act authorizes compensation to
Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Notices 45427

eligible organizations either on a

reasonable cost or a risk basis for

services provided under the Medicare

program. Frequency: one time; Affected

Public: Business or other for-profit, Notfor-profit institutions, and State, Local

or Tribal Government; Number of

Respondents: 65; Total Annual

Responses: 65; Total Annual Hours:

6,500.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: August 21, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–22744 Filed 8–26–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Council on Graduate Medical

Education Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of September 1997:

Name: Council on Graduate Medical

Education.

Date and Time: September 24, 1997, 1:00

p.m.–5:00 p.m. September 25, 1997, 8:30

a.m.–1:00 p.m.

Place: The Bethesda Ramada Inn, 8400

Wisconsin Avenue, Bethesda, Maryland

20814.

This meeting is open to the Public.

Agenda: The agenda will include

Geographic Distribution ‘‘1’’ Report final

review and action. Discussions of Draft

Minorities in Medicine Report and public

comments. Congressional staff presentations.

Pew Commission Physician Workforce task

force activities. Work plan and activities for

the year.

Anyone requiring information regarding

the subject should contact F. Lawrence Clare,

M.D., M.P.H., Deputy Executive Secretary,

telephone (301) 443–6326, Council on

Graduate Medical Education, Division of

Medicine, Bureau of Health Professions,

Room 9A–27, Parklawn Building, 5600

Fishers Lane, Rockville, Maryland 20857.

Agenda items are subject to change as

priorities dictate.

Date: August 21, 1997.

Jane M. Harrison,

Acting Director, Division of Policy Review

and Coordination and Information

Coordination.

[FR Doc. 97–22784 Filed 8–26–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

Amended Notice of Meeting

Notice is hereby given of a change in

the meeting of the National Advisory

Council on Drug Abuse, National

Institute on Drug Abuse (NIDA) on

September 16–17, 1997, at the National

Institutes of Health, Building 31, 9000

Rockville Pike, Bethesda, MD 20892,

which was published in the Federal

Register on August 13, 1997, Volume 62

FR 43337.

This committee was to have convened

from 9 a.m. to 4 p.m. on September 16,

and from 9 a.m. to 5 p.m. on September

17. On September 17 the time has been

changed to 9 a.m. to 12 p.m.

Dated: August 21, 1997.

LaVeen M. Ponds,

Policy Analyst, National Institutes of Health

Committee Management Officer.

[FR Doc. 97–22822 Filed 8–26–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Arthritis and

Musculoskeletal and Skin Diseases;

Notice of Meeting; National Arthritis

and Musculoskeletal and Skin

Diseases Advisory Council

Pursuant to Public Law 92–463,

notice is hereby given of a meeting of

the National Arthritis and

Musculoskeletal and Skin Diseases

Advisory Council to provide advice to

the National Institute of Arthritis and

Musculoskeletal and Skin Diseases

(NIAMS) on September 4, 1997, in

Conference Room 6, Building 31,

National Institutes of Health, Bethesda,

Maryland.

The meeting will be open to the

public September 4 from 8:30 a.m. to

12:00 p.m. to discuss administrative

details relating to Council business and

special reports. Attendance by the

public will be limited to space available.

The meeting of the Advisory Council

will be closed to the public on

September 4 from 1:00 p.m. to

adjournment in accordance with

provisions set forth in sections

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

and section 10(d) of Public Law 92–463,

for the review, discussion and

evaluation of individual grant

applications. These deliberations could

reveal confidential trade secrets or

commercial property, such as patentable

material, and personal information

concerning individuals associated with

the applications, disclosure of which

would constitute a clearly unwarranted

invasion of personal property.

This notice is being published less

than 15 days prior to the above meeting

due to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Dr. Steven Hausman, Executive

Secretary, National Arthritis and

Musculoskeletal and Skin Diseases

Advisory Council, NIAMS, Natcher

Building, Room 5AS–13, Bethesda,

Maryland 20892; (301) 594–2463.

A summary of the meeting and roster

of the members may be obtained from

the Extramural Programs Office,

NIAMS, Natcher Building, Room 5AS–

13, National Institutes of Health,

Bethesda, Maryland 20892; (301) 594–

2463.

(Catalog of Federal Domestic Assistance

Program No. 93.846, Arthritis, Bone and Skin

Diseases, National Institutes of Health.)

Dated: August 21, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–22826 Filed 8–26–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Division of Research Grants; Notice of

Closed Meetings

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