Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Rules and Regulations 64619

section has changed since the previous

report.

(c) When to report. Annual progress

reports for postmarketing study

commitments entered into by applicants

shall be reported to FDA within 60 days

of the anniversary date of the U.S.

approval of the application for the

product.

(d) Where to report. Submit two

copies of the annual progress report of

postmarketing studies to the Food and

Drug Administration, Center for

Biologics Evaluations and Research,

Document Control Center (HFM–99),

1401 Rockville Pike, Rockville, MD

20852–1448.

(e) Public disclosure of information.

Except for the information described in

this paragraph, FDA may publicly

disclose any information concerning a

postmarketing study, within the

meaning of this section, if the agency

determines that the information is

necessary to identify an applicant or to

establish the status of the study

including the reasons, if any, for failure

to conduct, complete, and report the

study. Under this section, FDA will not

publicly disclose trade secrets, as

defined in § 20.61 of this chapter, or

information, described in § 20.63 of this

chapter, the disclosure of which would

constitute an unwarranted invasion of

personal privacy.

Dated: October 13, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27731 Filed 10–26–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 94N–0380]

Gastroenterology and Urology

Devices; Effective Date of the

Requirement for Premarket Approval

of the Implanted Mechanical/Hydraulic

Urinary Continence Device; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of September 26, 2000 (65 FR

57726). The final rule requires the filing

of a premarket approval application or

a notice of completion of a product

development protocol for the implanted

mechanical/hydraulic urinary

continence device, a generic type of

medical device intended for the

treatment of urinary incontinence. In

the final rule, the effective date was

stated incorrectly. This document

corrects that error.

FOR FURTHER INFORMATION CONTACT:

Nicole L. Wolanski, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION: In FR Doc.

00–24632 appearing on page 57726 in

the Federal Register of September 26,

2000, the following correction is made:

1. On page 57726, in the second

column, under the EFFECTIVE DATE

caption, the date ‘‘October 26, 2000’’ is

corrected to read ‘‘September 26, 2000.’’

Dated: October 19, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–27736 Filed 10–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Department of the Air Force

32 CFR Part 811

RIN 0701–AA62

Release, Dissemination, and Sale of

Visual Information Materials

AGENCY: Department of the Air Force,

DoD.

ACTION: Final rule.

SUMMARY: The Department of the Air

Force is revising our rules on the

Release, Dissemination, and Sale of

Visual Information Materials to reflect

current polices. These rules implement

Air Force Instruction (AFI) 33–117,

Visual Information Management, and

apply to all Air Force activities.

EFFECTIVE DATE: December 1, 2000.

ADDRESSES: Mr. Raymond Dabney, HQ

AFCIC/ITSM, 1250 Air Force Pentagon,

Washington, DC 20330–1250, 703–588–

6136.

FOR FURTHER INFORMATION CONTACT: Mr.

Raymond Dabney, HQ AFCIC/ITSM,

703–588–6136.

SUPPLEMENTARY INFORMATION: The

Department of the Air Force is revising

our rules on the Release, Dissemination,

and Sale of Visual Information Materials

of the Code of Federal Regulations

(CFRs) (32 CFR part 811) to reflect

current policies. This part implements

Air Force Instruction (AFI) 33–117,

Visual Information Management, and

apply to all Air Force activities. This

part was published as a proposed rule

in the Federal Register on December 28,

1999 (64 FR 72621, FR Doc. 99–33604).

Comments were solicited for 60 days

ending on February 28, 2000. No

comments were received.

List of Subjects in 32 CFR Part 811

Archives and records, Motion

pictures.

For the reasons stated in the

preamble, the Department of the Air

Force is revising 32 CFR Part 811 to read

as follows:

PART 811—RELEASE,

DISSEMINATION, AND SALE OF

VISUAL INFORMATION MATERIALS

Sec.

811.1 Exceptions.

811.2 Release of visual information

materials.

811.3 Official requests for visual

information productions or materials.

811.4 Selling visual information materials.

811.5 Customers exempt from fees.

811.6 Visual information product/material

loans.

811.7 Collecting and controlling fees.

811.8 Forms prescribed and availability of

publications.

Authority: 10 U.S.C. 8013.

§ 811.1 Exceptions.

The regulations in this part do not

apply to:

(a) Visual information (VI) materials

made for the Air Force Office of Special

Investigations for use in an investigation

or a counterintelligence report. (See Air

Force Instruction (AFI) 90–301, The

Inspector General Complaints, which

describes who may use these materials.)

(b) VI materials made during Air

Force investigations of aircraft or

missile mishaps according to AFI 91–

204, Safety Investigations and Reports.

(See AFI 90–301.)

§ 811.2 Release of visual information

materials.

(a) Only the Secretary of the Air Force

for Public Affairs (SAF/PA) clears and

releases Air Force materials for use

outside Department of Defense (DoD),

according to AFI 35–205, Air Force

Security and Policy Review Program.

(b) The Secretary of the Air Force for

Legislative Liaison (SAF/LL) arranges

the release of VI material through SAF/

PA when a member of Congress asks for

them for official use.

(c) The International Affairs Division

(HQ USAF/CVAII) or, in some cases, the

major command (MAJCOM) Foreign

Disclosure Office, must authorize

release of classified and unclassified

64620 Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Rules and Regulations

materials to foreign governments and

international organizations or their

representatives.

§ 811.3 Official requests for visual

information productions or materials.

(a) Send official Air Force requests for

productions or materials from the DoD

Central Records Centers by letter or

message. Include:

(1) Descriptions of the images needed,

including media format, dates, etc.

(2) Visual information record

identification number (VIRIN),

production, or Research, development,

test, and evaluation (RDT&E)

identification numbers, if known.

(3) Intended use and purpose of the

material.

(4) The date needed and a statement

of why products are needed on a

specific date.

(b) Send inquiries about motion

picture or television materials to the

Defense Visual Information Center

(DVIC), 1363 Z Street, Building 2730,

March ARB, CA 92518–2703.

(c) Send Air Force customer inquiries

about still photographic materials to 11

CS/SCUA, Bolling AFB, Washington,

DC 20332–0403 (the Air Force

accessioning point).

(d) Send non-Air Force customers’

inquiries about still photographic

materials to the DVIC.

§ 811.4 Selling visual information

materials.

(a) Air Force VI activities cannot sell

materials.

(b) HQ AFCIC/ITSM may approve the

loan of copies of original materials for

federal government use.

(c) Send requests to buy:

(1) Completed, cleared, productions,

to the National Archives and Records

Administration, National Audiovisual

Center, Information Office, 8700

Edgeworth Drive, Capitol Heights, MD

20722–3701.

(2) Nonproduction VI motion media

to the DVIC. The center may sell other

Air Force VI motion picture and

television materials, such as historical

and stock footage. When it sells VI

motion media, the DVIC assesses

charges, unless § 811.5 exempts the

requesting activity.

(3) VI still media to the DoD Still

Media Records Center (SMRC), Attn:

SSRC, Washington, DC 20374–1681.

When SMRC sells VI still media, the

SMRC assesses charges, unless § 811.5

exempts the requesting activity.

§ 811.5 Customers exempt from fees.

Title III of the 1968 Intergovernmental

Cooperation Act (42 U.S.C. 4201, 4231,

and 4233) exempts some customers

from paying for products and loans.

This applies if the supplier has

sufficient funds and if the exemption

does not impair its mission. The

requesting agency must certify that the

materials are not commercially

available. When requests for VI material

do not meet exemption criteria, the

requesting agency pays the fees.

Exempted customers include:

(a) DoD and other government

agencies asking for materials for official

activities (see DoD Instruction 4000.19,

Interservice, and Intergovernmental

Support, August 9, 1995, and DoD

Directive 5040.2, Visual Information

(VI), December 7, 1987.

(b) Members of Congress asking for VI

materials for official activities.

(c) VI records center materials or

services furnished according to law or

Executive Order.

(d) Federal, state, territorial, county,

municipal governments, or their

agencies, for activities contributing to an

Air Force or DoD objective.

(e) Nonprofit organizations for public

health, education, or welfare purposes.

(f) Armed Forces members with a

casualty status, their next of kin, or

authorized representative, if VI material

requested relates to the member and

does not compromise classified

information or an accident investigation

board’s work.

(g) The general public, to help the

Armed Forces recruiting program or

enhance public understanding of the

Armed Forces, when SAF/PA

determines that VI materials or services

promote the Air Force’s best interest.

(h) Incidental or occasional requests

for VI records center materials or

services, including requests from

residents of foreign countries, when fees

would be inappropriate. AFI 16–101,

International Affairs and Security

Assistance Management, tells how a

foreign government may obtain Air

Force VI materials.

(i) Legitimate news organizations

working on news productions,

documentaries, or print products that

inform the public on Air Force

activities.

§ 811.6 Visual information product/

material loans.

(a) You may request unclassified and

classified copies of current Air Force

productions and loans of DoD and other

Federal productions from JVISDA,

ATTN: ASQV–JVIA–T–AS, Bldg. 3, Bay

3, 11 Hap Arnold Blvd., Tobyhanna, PA

18466–5102.

(1) For unclassified products, use

your organization’s letterhead, identify

subject title, PIN, format, and quantity.

(2) For classified products, use your

organization’s letterhead, identify

subject title, personal identification

number (PIN), format, and quantity.

Also, indicate that either your

organization commander or security

officer, and MAJCOM VI manager

approve the need.

(b) You may request other VI

materials, such as, still images and

motion media stock footage, from DVIC/

OM–PA, 1363 Z Street, Building 2730,

March ARB, CA 92518–2703.

§ 811.7 Collecting and controlling fees.

(a) The DoD records centers usually

collect fees in advance. Exceptions are

sales where you cannot determine

actual cost until work is completed (for

example, television and motion picture

services with per minute or per footage

charges).

(b) Customers pay fees, per AFR 177–

108, Paying and Collecting Transactions

at Base Level, with cash, treasury check,

certified check, cashier’s check, bank

draft, or postal money order.

§ 811.8 Forms prescribed and availability

of publications.

(a) AF Form 833, Visual Information

Request, AF Form 1340, Visual

Information Support Center Workload

Report, DD Form 1995, Visual

Information (VI) Production Request

and Report, DD Form 2054–1, Visual

Information (VI) Annual Report, and DD

Form 2537, Visual Information Caption

Sheet are prescribed by this part.

(b) Air Force publications and forms

referenced in this part are available from

NTIS, 5285 Port Royal Road,

Springfield, VA 22161 or online at

http://www.afpubs.hq.af.mil. DoD

publications are available at

http://www.defenselink.mil/pubs.

Janet A. Long,

Air Force Federal Register Liaison Officer.

[FR Doc. 00–27021 Filed 10–27–00; 8:45 am]

BILLING CODE 5001–05–P

DEPARTMENT OF DEFENSE

Department of the Air Force

32 CFR Parts 811a and 813

RIN 0701–AA63

Visual Information Documentation

Program

AGENCY: Department of the Air Force,

DoD.

ACTION: Final rule.

SUMMARY: The Department of the Air

Force is revising our rules on the Visual

Information Documentation Program of

the Code of Federal Regulations (CFRs)

to reflect current polices. These rules