64222 Federal Register / Vol. 65, No. 208 / Thursday, October 26, 2000 / Notices

STATUS: This meeting will be open to the

public.

ITEMS TO BE DISCUSSED:

Correction and Approval of Minutes.

Draft Advisory Opinion 2000–24;

Alaska Democratic Party by counsel,

Neil Reiff.

Statements of Reasons—Requests to

Deny Certification of Public Funds to

Patrick J. Buchanan and Ezola Foster

(LRA#598/599).

Notice of Disposition of Petition for

Rulemaking Filed by the Project on

Government Oversight.

Administrative Matters.

PERSON TO CONTACT FOR INFORMATION:

Mr. Ron Harris, Press Officer,

Telephone: (202) 694–1220.

Mary W. Dove,

Acting Secretary of the Commission.

[FR Doc. 00–27654 Filed 10–24–00; 11:49

am]

BILLING CODE 6715–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Committee on Vital and Health

Statistics; Meeting

Pursuant to the Federal Advisory

Committee Act, the Department of

Health and Human Services (HHS)

announces the following advisory

committee meeting.

Name: National Committee on Vital and

Health Statistics (NCVHS).

Time and Date: November 28, 2000—9

a.m.–5 p.m. EDT.

November 29, 2000—10:15 a.m.–3:30 p.m.

EDT.

Place: Hubert H. Humphrey Building, 200

Independence Avenue SW., Room 705A,

Washington, DC 20201.

Status: Open.

Purpose: At this meeting the Committee

will hear presentations and hold discussions

on several health data policy topics. On the

first day an update from HHS has been

scheduled on the implementation of the

administrative simplification provisions of

the Health Insurance Portability and

Accountability Act of 1996 (HIPAA). The

Committee will be briefed by the Director of

the National Center for Health Statistics on

several health data activities. In addition,

there may be a discussion of a possible draft

letter to the HHS Secretary regarding digital

signatures. The Committee will also discuss

action items reported in the summary from

its 50th Anniversary Symposium held earlier

in the year. There will also be a report on two

recent meetings of the World Health

Organization’s (WHO) collaborating Center

for the Classification of Diseases. A panel

discussion has been scheduled on HIPAA

implementation issues. The first day will end

with breakout sessions for subcommittees

and workgroups. Day two will also begin

with breakout sessions and then the full

committee will be briefed on selected HHS

data policy initiatives and will hear an

analysis of State privacy laws. The afternoon

session will be devoted to hearing reports

from the subcommittees and workgroups and

the setting of future agendas.

Notice: In the interest of security, HHS has

instituted stringent procedures for entrance

to the Hubert H. Humphrey building by nongovernment employees. Persons without a

government identification card may need to

have the guard call for an escort to the

meeting.

Contact Person for Core Information:

Substantive program information as well as

summaries of meetings and a roster of

committee members may be obtained from

Marjorie S. Greenberg, Executive Secretary,

NCVHS, National Center for Health Statistics,

Centers for Disease Control and Prevention,

Room 1100, Presidential Building, 6525

Belcrest Road, Hyattsville, Maryland 20782,

telephone (301) 458–4245. Information also

is available on the NCVHS home page of the

HHS website: http://www.ncvhs.hhs.gov/,

where further information including an

agenda will be posted when available.

Dated: October 18, 2000.

James Scanlon,

Director, Division of Data Policy, Office of

the Assistant Secretary for Planning and

Evaluation.

[FR Doc. 00–27462 Filed 10–25–00; 8:45 am]

BILLING CODE 4151–05–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1268]

Agency Information Collection

Activities; Announcement of OMB

Approval; Food Additives and Food

Additive Petitions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Food Additives and Food Additive

Petitions’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 3, 2000 (65

FR 47736), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 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 0910–0016. The

approval expires on October 31, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: October 20, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27546 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1373]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Reporting

and Recordkeeping Requirements for

Mammography Facilities

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.

DATES: Submit written comments on the

collection of information by November

27, 2000.

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: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

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.

Federal Register / Vol. 65, No. 208 / Thursday, October 26, 2000 / Notices 64223

Reporting and Recordkeeping

Requirements for Mammography

Facilities—21 CFR Part 900 (OMB

Control Number 0910–0309)—Extension

Public Law 102–539, the

Mammography Quality Standards Act of

1992 (MQSA) (42 U.S.C. 263b) as

amended by the Mammography Quality

Standards Reauthorization Act

(MQSRA) of 1998 (Public Law 105–248)

establishes the authority for a Federal

certification and inspection program for

mammography facilities; regulations

and standards for accreditation bodies

for mammography facilities; and

standards for mammography equipment,

personnel, and practices, including

quality assurance. MQSRA extended the

life of the MQSA program for 4 years

from its original expiration date of 1998

until 2002, and also modified some of

the provisions. The most significant

modification from a report and

recordkeeping viewpoint under 21 CFR

900.12(c)(2) was that mammography

facilities were required to send a lay

summary of each examination to the

patient.

FDA, under this regulation, collects

information from accreditation bodies

and mammography facilities by

requiring each accreditation body to

submit an application for approval and

to establish a quality assurance program.

On the basis of accreditation, facilities

are certified by FDA and must

prominently display their certificate.

FDA uses the information to ensure that

private, nonprofit organizations or State

agencies meet the standards established

by FDA for accreditation bodies to

accredit facilities that provide

mammography services. Information

collected from mammography facilities

has also been used to ensure that the

personnel, equipment, and quality

systems has and continues to meet the

regulations under MQSA and will be

used by patients to manage their health

care properly. The intent of these

regulations is to assure safe, reliable,

and accurate mammography on a

nationwide level. The most likely

respondents to this information

collection will be accreditation bodies

and mammography facilities seeking

certification.

In the Federal Register of July 17,

2000 (65 FR 44061), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Total

Capital

Costs

Total Operating

and Maintenance

Costs

900.3 6 1 6 60 360

900.3(b)(3) 10 1 10 60 600 $50

900.3(c) 4 0.14 0.56 15 8.4

900.3(e) 1 0.2 0.2 1 0.2

900.3(f)(2) 1 0.2 0.2 1 0.2

900.4(c) 834 1 834 1 834

900.4(e) 10,000 1 10,000 8 80,000

900.4(f) 1,000 1 1,000 14.5 14,500

900.4(h) 6 1 750 6 4,500

900.4(i)(2) 1 1 1 1 1

900.6(c)(1) 1 1 1 1 1

900.11(b)(2) 25 1 25 2 50

900.11(b)(3) 5 1 5 0.5 2.5

900.11(c) 10,000 0.0050 50 20 1,000 $1,000

900.12(c)(2) 9,800 4,080 39,984,000 5 minutes 3,332,000

900.12(j)(1) 10 1 10 1 10

900.15(d)(3)(ii) 10,000 0.0020 20 2 40 $100

900.18(c) 10,000 0.0005 6 2 12 $60

900.18(e) 10 0.1000 1 1 1 $10

Total 3,434,010 $50, $1,170

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency of

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Total Operating

and Maintenance Costs

900.3(f)(1) 10 130 1,300 200 2,000

900.4(g) 10,000 1 10,000 1 10,000

900.11(b)(1) 1,000 1 1,000 1 1,000

900.12(c)(4) 10,000 1 10,000 1 10,000

900.12(e)(13) 6,000 52 312,000 0.125 39,000

900.12(f) 10,000 1 10,000 1 10,000

900.12(h) 10,000 2 20,000 0.5 10,000 $20,000

Total 82,000 $20,000

1There are no capital costs associated with this collection of information.

All costs of implementing

requirements for certification of

mammography facilities will be borne

by accreditation bodies; the incremental

costs that accreditation bodies will face

are not expected to be significant. The

collection’s burden is based upon the

estimated number of summaries

received by FDA, which in turn is based

64224 Federal Register / Vol. 65, No. 208 / Thursday, October 26, 2000 / Notices

on the estimated number of

examinations expected to be performed

in a given year. If mammography

examinations increase in number in

subsequent years, which is expected for

at least the foreseeable future, the

annual burden and costs to meet this

requirement will increase.

Included in the burden estimate is the

FDA estimate for mammography lay

summaries, which is the practice of

notifying the patient in layman’s terms

of the results of the patient’s

mammography examination. FDA

estimates that there are 9,800 facilities

performing mammography in the United

States. FDA also estimates that those

facilities perform a total of 40 million

mammography examinations in a year.

In 90 percent of these cases, the

notification to the patient can be

established by a brief standardized letter

to the patient. FDA estimates that

preparing and sending this letter will

take approximately 5 minutes. In the 10

percent of the cases in which there is a

finding of ‘‘Suspicious’’ or ‘‘Highly

suggestive of malignancy,’’ the facility is

required to make reasonable attempts to

ensure that the results are

communicated to the patients as soon as

possible. FDA believes that this

requirement can be met by a 5-minute

call from the health professional to the

patient.

Dated: October 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27453 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Biological Response

Modifiers Advisory Committee.

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on November 16 and 17, 2000, 8:30 a.m. to

5:30 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Gail M. Dapolito or

Rosanna L. Harvey, Center for Biologics

Evaluation and Research (HFM–71), Food

and Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–827–0314, or

FDA Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12389. Please

call the Information Line for up-to-date

information on this meeting.

Agenda: On November 16 and 17, 2000,

the committee will meet to discuss the

following issues related to gene therapy

clinical trials: (1) Product characterization,

(2) preclinical models, and (3) long term

followup.

Procedure: Interested persons may present

data, information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by November 9,

2000. Oral presentations from the public will

be scheduled between approximately 1 p.m.

and 1:30 p.m. on November 16, 2000, and

from 9 a.m. to 9:30 a.m. on November 17,

2000. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify the

contact person before November 9, 2000, and

submit a brief statement of the general nature

of the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an indication of

the approximate time requested to make their

presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 18, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27455 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Science Board to the Food and Drug

Administration; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Science Board to the

Food and Drug Administration.

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on November 17, 2000, 8:30 a.m. to 5 p.m.

Location: Food and Drug Administration,

CDER Advisory Committee Meeting Room,

5630 Fishers Lane, Rockville, MD 20857.

Contact Person: Susan Mackie Bond, Office

of Science Coordination and Communication

(HF–33), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857,

301–827–6687, or FDA Advisory Committee

Information Line, 1–800–741–8138 (301–

443–0572 in the Washington, DC area), code

12603. Please call the Information Line for

up-to-date information on this meeting.

Agenda: The board will meet to hear and

to discuss the following issues: (1) Emerging

science issues at FDA, (2) strategies for

maintaining quality of science at FDA, and

(3) programmatic peer review.

Procedure: Interested persons may present

data, information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by November 7,

2000. Oral presentations from the public will

be scheduled between approximately 1 p.m.

to 2 p.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify the

contact person before November 7, 2000, and

submit a brief statement of the general nature

of the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an indication of

the approximate time requested to make their

presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 18, 2000.

Linda S. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27456 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F