63402 Federal Register / Vol. 69, No. 210 / Monday, November 1, 2004 / Notices 

this reason, the following changes are 

being proposed to the current form:

1. The expenditures columns will be 

reordered so that when reading left to 

right, the three types of funding that 

sum to total expenditures—SSBG 

allocation, funds transferred into 

SSBG, and expenditures of all other 

Federal, State, and local funds—are 

listed prior to total expenditures. 

2. A space will be added, and referenced 

in item 29, where States can report 

more detail about other services. This 

added information will help to define 

the specific services funded under 

this service category. 

3. The column for total adults will be 

removed. A new column, ‘‘Adults of 

Unknown Age’’ will be added. The 

three age groups of adults—‘‘Adults 

Age 59 and younger,’’ ‘‘Adults Age 60 

and older,’’ and ‘‘Adults of Unknown 

Age’’—should equal the total number 

of adults. 

4. The recipients columns will be 

reordered so that when reading left to 

right, the four ages of recipients—

children, adults age 59 and younger, 

adults age 60 and older, and adults of 

unknown age—are listed prior to total 

recipients.

The SSBG program provides funds to 

assist States in delivering social services 

directed toward the needs of children 

and adults in each State. Funds are 

allocated to the States in proportion to 

their populations. States, including the 

District of Columbia, Guam, Puerto 

Rico, the Virgin Islands, the Northern 

Mariana Islands, and American Samoa, 

have substantial discretion in their use 

of funds and may determine what 

services will be provided, who will be 

eligible, and how funds will be 

distributed among the various services. 

State or local SSBG agencies (i.e.,

county, city, or regional offices) may 

provide the services or may purchase 

them from qualified agencies, 

organizations, or individuals. States 

report as recipients of SSBG-funded 

services any individuals who receive a 

service funded at least partially by 

SSBG. 

States are required to report their 

annual SSBG expenditures on a 

standard postexpenditure report, which 

includes a yearly total of adults and 

children served and annual 

expenditures in each of 29 service 

categories. Reporting requirements for 

SSBG were originally described in the 

Federal Register, Volume 58, Number 

218, on Monday, November 15, 1993. 

The report is due either 6 months after 

the end of the reporting period or at the 

time the State submits the 

preexpenditure report for the reporting 

period beginning after that 6 month 

period. The report must address: (1) The 

number of individuals (as well as 

number of children and number of 

adults) who receive services paid for in 

whole or in part with Federal funds 

under the Social Services Block Grant; 

(2) The amount of Social Services Block 

Grant funds spent in providing each 

service; (3) The total amount of Federal, 

State, and local funds spent in 

providing each service, including Social 

Services Block Grant funds; and (4) The 

method(s) by which each service is 

provided, showing separately the 

services provided by public agencies 

and private agencies. 

Information collected on the 

postexpenditure report is analyzed and 

described in an annual report on SSBG 

expenditures and recipients produced 

by the Office of Community Services. 

The information contained in this report 

is used to establish how SSBG funding 

is used for the provision of services in 

each State to each of many specific 

populations of needy individuals. 

Respondents: This report is 

completed once annually by a 

representative of the agency that 

administers the Social Services Block 

Grant at the State level in each State, the 

District of Columbia, and the Territories.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents 

Number of

responses per 

respondent 

Average

burden hours 

per response 

Total burden 

hours 

Postexpenditure Report ................................................................................... 56 1 110 6,160 

Estimated Total Annual Burden 

Hours: 6,160. 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Information Services, 

370 L’Enfant Promenade, SW., 

Washington, DC 20477, Attn: ACF 

Reports Clearance Officer. E-mail 

address:grjohnson@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication.

Dated: October 26, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–24349 Filed 10–29–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0459]

Draft Guidance for Industry on 

Pharmacokinetics in Pregnancy—

Study Design, Data Analysis, and 

Impact on Dosing and Labeling

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Draft Guidance for 

Industry on Pharmacokinetics in 

Pregnancy—Study Design, Data 

Analysis, and Impact on Dosing and 

Labeling.’’ This guidance discusses 

agency recommendations on issues to 

consider when designing and 

Federal Register / Vol. 69, No. 210 / Monday, November 1, 2004 / Notices 63403

conducting pharmacokinetic (PK) 

studies in pregnant women and, 

specifically, on how to assess the 

influence of pregnancy on the PKs, and 

where appropriate, the 

pharmacodynamics (PD) of drugs or 

biologic products. The goals of this 

guidance are to recommend a 

framework for designing and conducting 

PK studies in pregnant women and 

stimulate further study and research to 

assist in rational therapeutics for 

pregnant patients.

DATES: Submit written or electronic 

comments on the draft guidance by 

January 3, 2005. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft 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, or the Office of 

Communications, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit written comments on the draft 

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. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Kathleen Uhl, Center for Drug 

Evaluation and Research (HFD–020), 

Food and Drug Administration, 5515 

Security Lane, Rockville, MD 20852, 

301–443–5157.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Draft Guidance for Industry on 

Pharmacokinetics in Pregnancy—Study 

Design, Data Analysis, and Impact on 

Dosing and Labeling.’’ This guidance is 

intended to provide recommendations 

to sponsors and investigators on how to 

design, conduct, and assess studies 

investigating the influence of pregnancy 

on the pharmacokinetics, and where 

appropriate, the pharmacodynamics of 

drugs or biologic products. During the 

clinical development of most products, 

pregnant women are actively excluded 

from trials, and, if pregnancy does occur 

during a trial, the usual procedure is to 

discontinue treatment and drop the 

patient from the study. Consequently, at 

the time of a drug’s initial marketing, 

except for products developed to treat 

conditions specific to pregnancy, there 

are seldom meaningful human data on 

the appropriate dosage and frequency of 

administration during pregnancy. Even 

after years of marketing, data in product 

labels regarding PK and dose 

adjustments during pregnancy rarely 

provide more information for 

appropriate prescribing in pregnancy 

than what was available at the time of 

initial marketing.

The information in this guidance is 

intended to promote an increase in the 

amount of useful data concerning how 

drug kinetics are affected by pregnancy 

and to further encourage the 

development of appropriate therapeutic 

treatments for pregnant women. Topics 

covered include ethical considerations 

associated with conducting PK studies 

in pregnant women, study design, data 

analysis, labeling, and considerations 

for future research. The agency 

recommends using this guidance in 

conjunction with other pharmacological 

and clinical literature on the design, 

conduct, and interpretation of PK 

studies. Because the conduct of studies 

in pregnant women requires specialized 

knowledge in a variety of areas, 

investigators designing such studies are 

encouraged to obtain advice from 

experts in fields such as obstetrics, 

pediatrics, pharmacology, clinical 

pharmacology, pharmacometrics, 

statistics, and other applicable 

disciplines.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. 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 submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination 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: October 21, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24308 Filed 10–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Funding Opportunity Title: Historically 

Black Colleges and Universities 

National Resource Center for 

Substance Abuse and Mental Health 

Service System Infrastructure 

Development (Short Title: HBCU–NRC) 

Announcement Type: Initial. 

Funding Opportunity Number: TI 05–

002. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.243.

DATES: Due Date for Applications:

January 18, 2005.

(Note: Letters from State Single Point of 

Contact (SPOC) in response to E.O. 12372 are 

due March 21, 2005.)

SUMMARY: The Substance Abuse and 

Mental Health Services Administration 

(SAMHSA), Center for Substance Abuse 

Treatment (CSAT) and Center for 

Mental Health Services (CMHS), 

announce the availability of FY 2005 

funds for a Historically Black Colleges 

and Universities National Resource 

Center (HBCU–NRC) for Substance 

Abuse and Mental Health Service 

System Infrastructure Development. A 

synopsis of this Notice of Funding 

Availability (NOFA), as well as many 

other Federal government funding 

opportunities, are also available at the 

Internet site: http://www.grants.gov.

For complete instructions, potential 

applicants must obtain a copy of 

SAMHSA’s standard Infrastructure 

Grants Program Announcement, INF–05 

PA, and the PHS 5161–1 (Rev. 7/00) 

application form before preparing and 

submitting an application. The INF–05 

PA describes the general program design 

and provides instructions for applying 

for all SAMHSA Infrastructure Grants, 

including the Historically Black 

Colleges and Universities National 

Resource Center for Substance Abuse 

and Mental Health Service System 

Infrastructure Development. SAMHSA’s 

Infrastructure Grants provide funds to