67930 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

designated population or group to the 

activities of the Center. 

CDC will require each ACE to form an 

ACE Community Committee. This group 

should comprise members of the ACE’s 

defined community and adult and youth 

representatives of agencies and 

organizations serving that community. 

The inputs provided by an ACE 

Community Committee to the ACE 

include guidance, advice on ACE 

agendas and plans, expertise, contacts, 

essential information about the 

designated community as well as 

intangible benefits. Some ACE’s may 

wish to form additional advisory 

groups, as needed, such as a policy 

board, a youth advisory board, or 

advisory committees for individual 

research projects. The decision to form 

these additional groups depends on the 

needs of the ACE and the community. 

Center Partnerships 

Each ACE is also expected to establish 

and maintain center partnerships with 

institutions such as state and local 

health, education justice departments, 

other university partners, other ACEs, 

Injury Control Research Centers (ICRCs), 

Prevention Research Centers, national 

youth violence prevention 

organizations, and CDC. Partnerships 

are intended to make the ACE’s 

surveillance, research, training and 

mentoring, community mobilizing and 

dissemination activities relevant to its 

identified community. Partners can 

collaborate with the ACE in designing 

and conducting research and other ACE 

projects and in disseminating research 

findings, which are expected to help 

facilitate the translation of public health 

research and related activities to 

practice and policy. 

Community-Based Participatory 

Research (CBPR) 

Scientific inquiry conducted in 

communities in which community 

members, persons affected by condition 

or issue under study and other key 

stakeholders in the community’s health 

have the opportunity to be full 

participants in each phase of the work 

(from conception—design—conduct—

analysis—interpretation—conclusions—

communication of results). 

Definition Developed by Inter Agency 

Working Group for CBPR, Convened by 

NIEHS, NIH, August 2, 2002 

According to the CARE–CDC Health 

Initiative, A Model for Global 

Participatory Research, in communitybased participatory research, the 

definition of scientific rigor is 

broadened to encompass community 

participation in decisionmaking at every 

phase of the research process: defining 

the problem, setting goals, selecting 

methods, interpreting data, and 

recommending policy. Essential to this 

philosophical construct is the assurance 

of quality decision making throughout 

the research process. In the document 

Building Community Partnerships in 

Research, participatory research is 

described as the gold standard toward 

which all federally funded research 

should aspire. (5)(p7). [Building 

Community Partnerships in Research: 

Recommendations and Strategies. 

Executive Summary. Washington, DC: 

U.S. Dept of Health and Human 

Services; April 7, 1998.]

[FR Doc. 04–25667 Filed 11–19–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0494]

Guidance for Industry on Changes to 

an Approved New Drug Application or 

Abbreviated New Drug Application; 

Specifications—Use of Enforcement 

Discretion for Compendial Changes

AGENCY: Food and Drug Administration.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Changes to an Approved NDA 

or ANDA; Specifications—Use of 

Enforcement Discretion for Compendial 

Changes.’’ This guidance informs new 

drug application (NDA) and abbreviated 

new drug application (ANDA) holders 

of FDA’s plan to use enforcement 

discretion with regard to the regulation 

on changes to an approved application. 

This regulation describes the filing 

requirement that a relaxation of 

acceptance criteria or deletion of a test 

to comply with an official compendium 

must be reported in a changes-beingeffected-in-30-days supplement (CBE–

30). FDA does not intend to take 

enforcement action if manufacturers 

continue to submit such changes in 

their annual reports. The use of 

enforcement discretion will give the 

agency time to clarify that some of these 

types of postapproval changes can be 

submitted in an annual report, rather 

than in a CBE–30. The agency intends 

to clarify this issue in an upcoming 

revision to a guidance for industry.

DATES: Submit written or electronic 

comments on agency guidances at any 

time.

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. 

Requests and comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

David J. Cummings, Center for Drug 

Evaluation and Research (HFD–357), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–443–5187.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of April 8, 

2004 (69 FR 18728), FDA published a 

final rule entitled ‘‘Supplements and 

Other Changes to an Approved 

Application.’’ In the same issue of the 

Federal Register (69 FR 18768), FDA 

announced the availability of the 

guidance for industry entitled ‘‘Changes 

to an Approved NDA or ANDA’’ (the 

changes guidance). Under 

§ 314.70(c)(2)(iii) (21 CFR 

314.70(c)(2)(iii)) of the final rule, the 

relaxation of an acceptance criterion or 

deletion of a test to comply with an 

official compendium that is consistent 

with FDA statutory and regulatory 

requirements must be submitted as a 

CBE–30 (see section VIII.C.1.e of the 

changes guidance).

FDA is issuing this guidance to 

explain that it is using enforcement 

discretion with regard to 

§ 314.70(c)(2)(iii) to address concerns 

raised by stakeholders. FDA plans to 

clarify that some of these types of 

changes can be submitted in an annual 

report, instead of a CBE–30 supplement, 

in a revision of the guidance for 

industry entitled ‘‘Changes to an 

Approved NDA or ANDA; Questions 

and Answers.’’

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collection of information in 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67931

this guidance was approved under OMB 

Control No. 0910–0001 and 0910–0032.

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on these topics. 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 requirements of the 

applicable statutes and regulations.

II. Comments

Interested persons may at any time 

submit to the Division of Dockets 

Management written or electronic 

comments on the guidance (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. The guidance and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

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

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: November 13, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25748 Filed 11–19–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

eriodically, the Health Resources and 

Services Administration (HRSA) publi 

tracts of information collection requests 

under review by the Office of 

Management and Budget, in compliance 

with the Paperwork Reduction Act of 

1995 (44 U.S.C. Chapter 35). To request 

a copy of the clearance requests 

submitted to OMB for review, call the 

HRSA Reports Clearance Office on (301) 

443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: The Division of 

Independent Review Grant Reviewer 

Recruitment Form—New 

HRSA’s Division of Independent 

Review (DIR) is responsible for carrying 

out the independent review of all 

eligible applications submitted to 

HRSA. DIR ensures that the 

independent review process is efficient, 

effective, economical and complies with 

statutes, regulations and policies. The 

review of applications is performed by 

people knowledgeable in the field of 

endeavor for which support is requested 

and is advisory to individuals in HRSA 

responsible for making award decisions. 

To streamline the collection, selection 

and assignment of grant reviewers to 

independent review committees, HRSA 

will utilize a Web-based data collection 

form to gather critical reviewer 

information. The Grant Reviewer 

Recruitment Form will standardize 

pertinent categories of reviewer 

information, such as areas of expertise, 

occupations, work settings, reviewer 

experience, and allow maximum use of 

drop-down menus to simplify for the 

data collection process. All selfnominated reviewers will be channeled 

to the Grant Reviewer Recruitment 

Form. DIR anticipates a monthly volume 

of approximately 100 self-nominated 

responses. On a periodic basis, existing 

HRSA reviewers will be notified and 

directed to update their profile (via the 

Grant Reviewer Recruitment Form). 

HRSA maintains a pool of 

approximately 5,000 individuals that 

have previously served on HRSA 

independent review committees. DIR 

projects that approximately 3,700 

individuals (or 75% of existing 

reviewers) would comply with 

instructions to update their profile on 

the Web-based Recruitment Form. 

For existing HRSA reviewers, the 

amount of time required to complete the 

Recruitment Form will be abbreviated 

since HRSA will fill in the Form with 

previously collected personal 

information; existing reviewers will 

focus only on updating changes (e.g.,

addresses, employer, expertise, 

occupation) to their profile. The 

estimate of burden for the HRSA Grant 

Reviewer Recruitment Form is as 

follows:

Type of respondent * Number of respondents 

Responses 

per respondent 

Total responses Minutes per 

response 

Total burden 

hours 

New reviewer ....................................................................... 1,200 1 1,200 45 900

Existing reviewer .................................................................. 3,700 1 3,700 30 1850

Total .............................................................................. 4,900 ........................ 4,900 ........................ 2,750

* Includes two categories of grant reviewers: (1) new or self-nominated reviewers that have never served as a HRSA grant reviewer and (2) 

existing reviewers that have previously served on a HRSA independent review committee. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

John Kraemer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503.

Dated: November 15, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–25751 Filed 11–19–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Cooperative Agreement for the 

International AIDS Education and 

Training Center; CFDA 93.145

AGENCY: Health Resources and Services 

Administration, HHS.

ACTION: Notice of supplemental award.