Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices 7791

2722, under the index ‘‘AERS Public

Meeting,’’ document No. 0510.

Information about the meeting will be

available via Internet using the World

Wide Web (WWW). To connect to the

CDER home page, type http://

www.fda.gov/cder and go to the

‘‘What’s Happening’’ section. Also

available on the CDER home page is a

link to the new AERS home page, which

contains a brief summary of the

materials that will be discussed at the

meeting. Information distributed at the

public meeting will be available from

the Freedom of Information Office (HFI–

35), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, approximately 10 business days

after the meeting at a cost of 10 cents

per page.

The agenda will be placed on display,

under the docket number found in

brackets in the heading of this

document, at the Dockets Management

Branch (HFA–305), 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Robert C. Nelson, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–700),

5600 Fishers Lane, Rockville, MD

20857, 301–827–3206.

SUPPLEMENTARY INFORMATION: The

primary purpose of FDA’s

postmarketing surveillance program is

to identify potentially serious drug

safety problems, focusing especially on

newly marketed drugs. Although

premarket testing discloses a general

safety profile of a new drug’s

comparatively common adverse effects,

the larger and more diverse patient

populations exposed to the marketed

drug provides, for the first time, the

opportunity to collect information on

rare, latent, and long-term effects.

Reports are obtained from a variety of

sources, including patients, treating

physicians, foreign regulatory agencies,

and clinical investigators. Over 75

percent of the ADR reports that FDA

receives are routed from health care

practitioners through pharmaceutical

companies. The remainder of the reports

come directly to FDA through the

agency’s MedWatch program.

FDA’s computerized spontaneous

reporting system (SRS) contains 1.4

million ADR reports for human drugs

and therapeutic biologics. FDA plans to

replace SRS with AERS by September

1997. All SRS historical data will be

migrated to AERS. AERS will enable

FDA to receive reports from

pharmaceutical companies by electronic

submission, transmitted data base to

data base through standardized

pathways. The technical specifications

of the AERS computerized system will

be described at the public meeting and

made available to participants,

especially as they relate to the electronic

submission of expedited and periodic

ADR reports.

FDA has participated in the

development of several guidelines by

the International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH)

that relate to the submission of ADR

reports under the AERS system:

‘‘Clinical Safety Data Management:

Definitions and Standards for Expedited

Reporting’’ (E2A); ‘‘Clinical Safety Data

Management: Data Elements for

Transmission of Individual Case Safety

Reports’’ (E2B); and ‘‘Clinical Safety

Data Management: Periodic Safety

Update Reports for Marketed Drugs’’

(E2C). In addition, two other guidelines

are currently under development by

ICH: ‘‘Medical Terminology

(MEDDRA)’’ (M1) and ‘‘Electronic

Standards for the Transfer of Regulatory

Information (ESTRI)’’ (M2).

At the public meeting, FDA will

explain how it intends to incorporate

these recommended standards into the

requirements for the electronic

submission of ADR reports under AERS.

The meeting will include a general

discussion of CDER’s plans to propose

revisions to its postmarketing ADR

reporting regulations. The goals of this

rulemaking are to implement the

recommendations in the ICH guidelines

and to enhance the quality of ADR

reports received by the agency. The

agency hopes to familiarize the

pharmaceutical industry with the

procedures for the electronic

submission of ADR reports under AERS

so that they are prepared to comply with

any revised regulations that may issue

as a result of the rulemaking initiative.

Additional information on the

technical specifications of the AERS

system will be placed on display, as

they are available in final form, at the

Dockets Management Branch (address

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

Monday through Friday.

Dated: February 13, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4161 Filed 2–19–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Form # HCFA–P–15A]

Emergency Clearance: Public Information

Collection Requirements Submitted to the

Office of Management and Budget (OMB)

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 (DHSS), has submitted

to the Office of Management and Budget

(OMB) the following request for

Emergency review. We are requesting an

emergency review because the

collection of this information is needed

prior to the expiration of the normal

time limits under OMB’s regulations at

5 CFR, Part 1320, thus causing the

disruption of this collection of

information, which is essential to the

agency’s mission of ensuring that

beneficiary needs are evaluated and

implemented, to the extent possible, in

a cost-effective manner. The Agency

cannot reasonably comply with the

normal clearance procedures because

public harm is likely to result if normal

clearance procedures are followed.

Without this information, HCFA would

not be able to properly determine the

services needed by beneficiaries or the

most cost efficient manner to meet

beneficiary needs, possibly resulting in

the denial of beneficiary warranted

services and a loss of program dollars.

HCFA is requesting that OMB provide

a 24-hour review and a 180-day

approval. During this 180-day period

HCFA will pursue OMB clearance of

this collection as stipulated by 5 CFR

1320.5.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Medicare

Current Beneficiary Survey (MCBS)

Round 18; Form No.: HCFA–P–15A;

Use: The MCBS is a continuous,

multipurpose survey of a nationally

representative sample of aged and

disabled persons for Medicare. The

survey provides a comprehensive source

of information on beneficiary

characteristics, needs, and satisfaction

with Medicare-related activities. The

proposed MCBS revisions will focus on

the evaluation of beneficiary

informational needs. This information

will enable HCFA to better coordinate

and integrate its current communication

objectives effectively and efficiently;

Frequency: On occasion; Affected

Public: Individuals and households;

Number of Respondents: 16,000; Total

Annual Responses: 16,000; Total

Annual Hours: 16,000.
7792 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices

To request copies of the proposed

paperwork collections referenced above,

call the Reports Clearance Office on

(410) 786–1325. Written comments and

recommendations for the proposed

information collections should be faxed

to OMB at (202) 395–6974, or sent

within 48 hours of this notice directly

to the OMB Desk 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: February 18, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–4337 Filed 2–19–97; 8:45 am]

BILLING CODE 4120–03–P

National Institutes of Health

National Institute of Arthritis and

Musculoskeletal and Skin Diseases;

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 Institute of Arthritis and

Musculoskeletal and Skin Diseases

Special Emphasis Panel (SEP) meeting:

Name of SEP: Alendronate.

Date: February 18, 1997.

Time: 3:00 p.m. - adjournment.

Place: NIAMS Review Branch, 45 Natcher

Building, Bethesda, Maryland 20892.

Contact Person: Melvin H. Gottlieb, Ph.D.,

Natcher Building, 45 Center Drive, Rm 5AS–

25U, Bethesda, Maryland 20892–6500,

Telephone: 301–594–4952.

Purpose/Agenda: To evaluate and review

an individual contract proposal. The meeting

will be closed in accordance with the

provisions set forth in sections 552b(c)(4) and

552b(c)(6), Title 5 U.S.C. The discussion of

this proposal could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

proposal, the disclosure of which would

constitute a clearly unwarranted invasion of

personal privacy.

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.

(Catalog of Federal Domestic Assistance

Program Nos. [93.846, Project Grants in

Arthritis, Musculoskeletal and Skin Diseases

Research], National Institutes of Health,

HHS)

Dated: February 13, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–4260 Filed 2–14–97; 4:34 pm]

BILLING CODE 4140–01–M

National Institute of Mental Health;

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

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: February 20, 1997.

Time: 8 a.m.

Place: Hyatt Regency Bethesda, One

Bethesda Metro Center, Bethesda, MD 20814.

Contact Person: Rehana A. Chowdhury,

Parklawn, Room 9C–26, 5600 Fishers Lane,

Rockville, MD 20857, Telephone: 301–443–

6470.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: March 6, 1997.

Time: 2 p.m.

Place: Parklawn, Room 9C–26, 5600

Fishers Lane, Rockville, MD 20857.

Contact Person: Lawrence E. Chaitkin,

Parklawn, Room 9C–26, 5600 Fishers Lane,

Rockville, MD 20857, Telephone: 301–443–

4843.

The meetings will be closed in accordance

with the provisions set forth in secs.

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

applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than

fifteen days prior to the meetings due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: February 13, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–4261 Filed 2–14–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4200–N–25]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due: April 21, 1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Reports Liaison Officer, Shelia E. Jones,

Department of Housing & Urban

Development, 451—7th Street, SW,

Room 7230, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Donner Buchet (202) 708–2290 (this is

not a toll-free number) for copies of the

proposed forms and other available

documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35 as amended).

The Notice is soliciting comments

from members of the public and affected

agencies concerning the proposed

collection of information to: (1) Evaluate

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(2) Evaluate the accuracy of the agency’s

estimate of the burden of the proposed

collection of information; (3) Enhance

the quality, utility, and clarity of the

information to be collected; and (4)

Minimize the burden of the collection of

information on those who are to

respond; including through the use of

appropriate automated collection

techniques or other forms of information

technology, e.g., permitting electronic

submission of responses.

This Notice also lists the following

information:

Title of Proposal: Designation of 20

Community Development Corporations

for authority to offer tax credits for

contributions.

OMB Control Number, if applicable:

Description of the need for the

information and proposed use: To

assess progress of designated CDCs in

accomplishing the program and

activities for which they received

designation.

Agency form numbers, if applicable:

Members of affected public: Staff of

the 20 community development

corporations (CDCs).