64840 Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices

Persons who are not registered in

advance will not be permitted into the

Federal Building and thus not be able to

attend the meeting. Persons attending

the meeting will be required to show a

photographic identification, preferably a

valid drivers’ license before entering the

building. Please note that if the meeting

is cancelled we will post that

information on our website.

Attendees will be provided with

meeting materials at the time of the

meeting. Written meeting materials will

be posted on the CMS website before the

January 16, 2002 meeting at: http://

www.hcfa.gov and http://

www.cms.hhs.gov. We will accept

written questions about meeting

logistics or requests for meeting

materials either before the meeting or up

to 14 days after the meeting. Written

submissions must be sent to:

Aspen Systems Corporation, ATTN:

Kim Slaughter, 2275 Research

Boulevard, Mail Stop 5W, Rockville,

Maryland 20850.

You may also contact Encounter Data

Representative: Kim Slaughter,

Telephone Number: (301) 519–5388,

Fax Number: (301) 519–6360, E-mail:

encounterdata@aspensys.com.

Written public comments will be

accepted until February 1, 2002. Written

public comments should be sent to

Bobbie Knickman at

bknickman@cms.hhs.gov or fax to (410)

786–1048.

(Authority: Sections 1851 through 1859 of

the Social Security Act (42 U.S.C. 1395w–21

through 1395w–28))

(Catalog of Federal Domestic Assistance

Program No. 93.773 Medicare—Hospital

Insurance Program; and No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: December 11, 2001.

Thomas A. Scully,

Administrator, Centers for Medicare &

Medicaid Services.

[FR Doc. 01–30991 Filed 12–13–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0393]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Prescription Drug Product Labeling;

Medication Guide Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by January 14,

2002.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Stuart

Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Prescription Drug Product Labeling;

Medication Guide Requirements (OMB

Control No. 0910–0393)—Extension

FDA regulations require the

distribution of patient labeling, called

Medication Guides, for certain

prescription human drug and biological

products used primarily on an

outpatient basis that pose a serious and

significant public health concern

requiring distribution of FDA-approved

patient medication information. These

Medication Guides inform patients

about the most important information

they should know about these products

in order to use them safely and

effectively. Included are information

such as the drug’s approved uses,

contraindications, adverse drug

reactions, and cautions for specific

populations, with a focus on why the

particular product requires a Medication

Guide. These regulations are intended to

improve the public health by providing

information necessary for patients to use

certain medication safely and

effectively.

The regulations contain the following

reporting requirements that are subject

to the PRA. The estimates for the burden

hours imposed by the following

regulations are listed in table 1 of this

document:

21 CFR 208.20—Applicants must

submit draft Medication Guides for FDA

approval according to the prescribed

content and format.

21 CFR 314.70(b)(3)(ii) and

601.12(f)—Application holders must

submit changes to Medication Guides to

FDA for prior approval as supplements

to their applications.

21 CFR 208.24(e)—Each authorized

dispenser of a prescription drug product

for which a Medication Guide is

required, when dispensing the product

to a patient or to a patient’s agent, must

provide a Medication Guide directly to

each patient unless an exemption

applies under § 208.26 (21 CFR 208.26).

Section 208.26(a)—Requests may be

submitted for exemption or deferral

from particular Medication Guide

content or format requirements.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency

per Response

Total Annual

Responses Hours per Response Total Hours

208.20 8 1 8 242 1,936

314.70(b)(3)(ii) and

601.12(f) 3 1 3 24 72

208.24(e) 55,000 8.3 460,000 .0014 644

208.26(a) 1 1 1 4 4

Total 2,656

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

In the Federal Register of September

25, 2001 (66 FR 49024), the agency

requested comments on the proposed

collections of information. FDA

received one comment on the

September 25, 2001, notice. The

Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices 64841

comment stated that clarification is

needed as to whether Medication

Guides would be needed for medical

devices that have a prescription drug

either as a coating or incorporated into

the material of the device, or as a

component in a kit. The comment said

that some of these types of products

might be considered combination

products.

FDA requested comments on the

information collection burden estimates

described in the notice. Because the

comment does not pertain to the burden

estimates, FDA has forwarded the

comment to Docket Number 93N–0371,

‘‘Prescription Drug Product Labeling;

Medication Guide Requirements.’’ FDA

appreciates the comment and will

consider it as part of its Medication

Guide program.

Dated: December 7, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–30852 Filed 12–13–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney 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

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis, Panel.

Date: January 6–8, 2002.

Time: 7 p.m. to 12 p.m.

Agenda: To review and evaluate grant

applications.

Place: Hotel Wales, 1295 Madison Avenue,

New York, NY 10128.

Contact Person: Francisco O. Calvo, PhD,

Chief, Review Branch, DEA, NIDDK, Room

752, 6707 Democracy Boulevard, National

Institutes of Health, Bethesda, MD 20892–

6600, (301) 594–8897.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.847, Diabetes,

Endocrinology and Metabolic Research;

93.848, Digestive Diseases and Nutrition

Research; 93.849, Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health, HHS)

Dated: December 5, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–30874 Filed 12–13–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Deafness and

Other Communications Disorders;

Notice of 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 a meeting of the

National Deafness and Other

Communications Disorders Advisory

Council.

The meeting will be open to the

public as indicated below, with

attendance limited to space available.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below

in advance of the meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

discussions could disclose confidential

trade secrets or commercial property

such as patentable material, and

personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Deafness and

Other Communication Disorders Advisory

Council.

Date: January 18, 2002.

Open: 8:30 a.m. to 11:15 a.m.

Agenda: Staff reports on divisional,

programmatic, and special activities.

Place: 31 Center Drive, Bldg. 31, Conf. Rm.

6, Bethesda, MD 20892.

Closed: 11:15 a.m. to Adjournment.

Agenda: To review and evaluate grant

applications.

Place: 31 Center Drive, Bldg. 31, Conf. Rm.

6, Bethesda, MD 20892.

Contact Person: Craig A. Jordan, PhD,

Chief, Scientific Review Branch, NIH/

NIDCD/DER, Executive Plaza South, Room

400C, Bethesda, MD 20892–7180, 301–496–

8683.

In the interest of security, NIH has

instituted stringent procedures for entrance

into the building by non-government

employees. Persons without a government

I.D. will need to show a photo I.D. and signin at the security desk upon entering the

building.

Information is also available on the

Institute’s/Center’s home page:

www.nidcd.nih.gov/about/councils/ndcdac/

ndcdac.htm, where an agenda and any

additional information for the meeting will

be posted when available.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.173, Biological Research

Related to Deafness and Communicative

Disorders, National Institutes of Health, HHS)

Dated: December 5, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–30875 Filed 12–13–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; 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

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Child Health and Human Development

Special Emphasis Panel, Mental Retardation

and Developmental Disabilities.

Date: December 10, 2001.

Time: 11 a.m. to 12 p.m.

Agenda: To review and evaluate grant

applications.

Place: 6100 Executive Blvd., Room 5E01,

Rockville, MD 20852 (Telephone Conference

Call).

Contact Person: Norman Chang, PhD,

Scientific Review Administrator, Division of

Scientific Review, National Institute of Child

Health and Human Development, National

Institute of Health, 6100 Executive Blvd.,

Room 5E03, Bethesda, MD 20892, (301) 496–

1485.

This notice is being published less than 15

days prior to the meeting due to the timing