Federal Register / Vol. 65, No. 193 / Wednesday, October 4, 2000 / Notices 59191

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcements Nos. OCS–2000–

01 and OCS–2001–01]

Request for Applications for the Office

of Community Services’ Fiscal Years

2000 and 2001 Discretionary Grants

Program; Correction

AGENCY: Office of Community Services

(OCS), ACF, DHHS.

ACTION: Notice; clarification and

correction.

SUMMARY: This notice clarifies Program

Announcement No. OCS–2000–01

published in the Federal Register on

August 19, 1999 (64 FR 45302) and

corrects Program Announcement No.

OCS–2001–01, published on June 20,

2000 (65 FR 38336). This notice clarifies

the Rural Community Facilities

Development Program Sub-Priority Area

2.0; it explains what information should

have been included in the FY 2000

announcement; and it corrects the error

made requesting proposals in the FY

2001 announcement. OCS will not be

accepting proposals for FY 2001 under

the Rural Community Facilities

Development Program—Sub-Priority

Area 2.1.

FOR FURTHER INFORMATION CONTACT:

Veronica Terrell, Administration for

Children and Families, Office of

Community Services, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Phone: 202–401–5295.

For Fiscal Year (FY) 2000: Program

Announcement, OCS–2000–01, issued

in the Federal Register on August 19,

1999, the information provided on page

45304 in the last paragraph under 3.

Project and Budget Periods, states ‘‘For

Priority Area 2.0, grantees will be

funded for 24 month project periods and

12 month budget periods.’’ OCS did not

mention that the program awardees

selected through the competitive

process in this round would be awarded

a ‘‘Non-Competitive Continuation

Grant’’ for FY 2001.

For FY 2001: Program

Announcement, OCS–2000–01, issued

in the Federal Register on June 20,

2000, OCS makes the following

corrections:

1. On page 38338—Under 3. Project

and Budget Periods: delete the last

paragraph and replace it with the

following note:

Note: There will be no new grant awards

made in Fiscal Year 2001 under Sub-Priority

Area 2.1. In Fiscal Year 2000, certain grantees

were awarded grants for 24-month project

periods and 12 month budget periods. These

grantees will receive the grant funds from

this category to supplement their second year

of funding.

2. On page 38344—Priority Area 2.0

Rural Community Facilities

Development should be corrected as

follows:

FY 2001 in the first heading and the

first sentence should be revised to ‘‘FY

2000.’’

The initial 1. should be removed.

The last paragraph should be removed

and replaced with a new paragraph to

read as follows: ‘‘One grant of

approximately $300,000 is anticipated

to be made under this sub-priority area

for FY 2000.

Remove section 2., Rural Community

Facilities, in its entirety. OCS does not

intend to compete this sub-priority area

for FY 2001. The FY 2000 grantees do

not have to apply competitively; their

FY 2001 grants will be administered as

a non-competitive continuation grant

action. At an appropriate time, OCS will

invite these grantees to submit requests

for continuation funding for the balance

of their two-year projects, subject to the

availability of funds.

Dated: September 29, 2000.

Robert L. Mott,

Deputy Director, Office of Community

Services.

[FR Doc. 00–25476 Filed 10–3–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nutrient Requirements of Domestic

Animals and Critical Roles of Animal

Nutrition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for

Veterinary Medicine, announces the

availability of funds to support an

unsolicited grant application submitted

by the National Academy of Sciences

(NAS). The academy has requested

funds to support the activities of the

National Research Council’s (NRC)

Committee on Animal Nutrition (CAN).

The central emphasis of CAN, through

its species subcommittees is the

preparation and updating of a series of

reports on the nutrient requirements of

animals. This series addresses

economically important domestic

animals, including food- and fiberproducing species, as well as captive

fur-bearing species, aquatic species,

companion animals, service and

working animals, endangered species,

and animals that serve as experimental

models in biomedical research. In

addition CAN identifies emerging

problems in the area of animal nutrition

and implements appropriate

mechanisms, such as deliberative

studies, symposia, workshops, or

roundtables to address the issues.

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Peggy L. Jones, Division

of Contracts and Procurement

Management (HFA–520), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

827–7160. Correspondence handcarried or commercially delivered

should be addressed to 5630 Fishers

Lane (HFA–520), rm. 2129,

Rockville, MD 20857.

Regarding the programmatic aspects

of this notice: David B. Batson,

Office of Research, Center for

Veterinary Medicine (HFV–502),

Food and Drug Administration,

8401 Muirkirk Rd., Laurel, MD

20708, 301–827–8021.

SUPPLEMENTARY INFORMATION:

I. Eligible Applicants

Assistance will only be provided to

the National Academy of Sciences

because of the following:

1. The NAS is the only organization

that submitted an unsolicited

application for the purpose stated

above.

2. The NAS is the only organization

that has a standing Committee on

Animal Nutrition for the purpose of

preparing and updating reports on the

nutrient requirements of animals.

3. The NRC is unique with regard to

its operation and policies. The core of

the NRC’s work consists of studies

conducted by experts selected by the

NRC expressly for their expertise in the

relevant scientific issues at hand.

4. CAN was formally organized in

1928 under the auspices of the NAS and

NRC to provide advice to Federal

agencies and the nation on the

nutritional management of important

domestic animals.

5. Reports produced by CAN have

been widely used and accepted by

Federal agencies, the biomedical

community, the U.S. animal industry

and abroad as a group of unbiased and

comprehensive reports that form the

basis of nutrient recommendations for

animals in the United States and many

parts of the world.

6. Reports of CAN have been

translated into at least five other

59192 Federal Register / Vol. 65, No. 193 / Wednesday, October 4, 2000 / Notices

languages (Spanish, Russian, Chinese,

Japanese, and Turkish) and are used as

a standard for animal nutrition

throughout the world.

II. Funding

We anticipate that approximately

$20,000 will be made available to fund

this project. It is expected that the

award will begin in either fiscal year

(FY) 2000 or FY 2001 and will be made

for a 12-month budget period within a

project period of up to 3 years. Funding

estimates may change. Continuation

awards within an approved project

period will be made on the basis of

satisfactory progress as evidenced by

required reports and the availability of

funds.

Dated: September 28, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–25449 Filed 10–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1519]

Clinical Pharmacology During

Pregnancy; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

FDA/National Institute for Child Health

and Human Development co-sponsored

meeting on ‘‘Clinical Pharmacology

During Pregnancy: Addressing Clinical

Needs Through Science.’’ Experts from

industry, academia, and the public have

been invited to provide their

perspectives on drug therapeutics

during the second and third trimester of

pregnancy. The goals of the meeting are:

To summarize the state of knowledge

regarding clinical pharmacology in

pregnancy; to raise awareness among

clinician researchers and leaders about

the need for clinical research and

collaboration in this area; and to garner

support for such research from health

advocacy groups and others.

DATES: The meeting will be held on

Monday and Tuesday, December 4 and

5, 2000, from 8 a.m. to 5 p.m. The

deadline for registration is November

13, 2000.

ADDRESSES: The location of the meeting

is the Holiday Inn, Capitol room, 550 C

St. SW., Washington, DC 20024, 202–

479–4000. Transcripts of the meeting

will be available from the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852,

and on the Internet at http://

www.fda.gov/ohrms/dockets. Register

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

cder/audiences/women/

pharmpreg2000.htm.

FOR FURTHER INFORMATION CONTACT:

Dianne L. Kennedy, Center for Drug

Evaluation and Research (HFD–104),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857 301–

827–2185, e-mail:

kennedyd@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Most women and physicians seek to

avoid the use of medications during

pregnancy to protect the developing

fetus from any potential adverse effects.

However, medication use by pregnant

women is common. A study conducted

in 1994 by FDA, using several managed

care data bases, found that the average

number of prescriptions per patient

during pregnancy (excluding prenatal

vitamins, iron preparations, and

medications at the time of delivery) was

three. The number of prescriptions

increased with maternal age. For

pregnant women over the age of 35, the

average number of prescriptions was

five (unpublished data, FDA).

In considering the needs for clinical

pharmacology data to guide drug dosing

among special populations, the pregnant

woman is rarely addressed. Yet, the

physiology of pregnancy is dynamic and

capable of influencing the

pharmacokinetic profiles of many drugs.

It is commonly appreciated that

hormonal changes, particularly elevated

estrogens and progesterone, accompany

normal pregnancy, but their effects are

often unappreciated.

Many women enter pregnancy with

health conditions that require

medications, such as neurologic and

psychiatric conditions. Some health

conditions tend to worsen during

pregnancy, including hypertension,

asthma, endocrinopathies,

rheumatologic diseases, and cardiac

conditions. Previously healthy women

often develop illnesses during

pregnancy, such as infections, diabetes,

thyroid disease, thromboembolism, or

cancers. Often, not using medications

poses far greater risk to fetal well being

and survival than the risk of a particular

drug.

Most physicians seek to prescribe the

lowest effective dose of any given drug

to treat a pregnant woman. Their goal is

to provide the best effect for the least

exposure possible to the fetus. However,

when deciding what the appropriate

dose is for a given patient, health care

practitioners usually rely on

information (typically from product

circulars) from studies of individuals

who are not pregnant. Particularly for

drugs with a narrow therapeutic

window, or with marginal efficacy at the

lower end of the therapeutic spectrum,

this practice risks exposing the fetus to

a dose of medication with little or no

benefit to the mother. The result may be

that the mother’s condition worsens.

She may require a second course of the

same treatment or a switch to a second

or third drug, exposing her developing

infant to multiple courses of treatment

over a much longer period of time.

Pregnant women are usually excluded

from clinical trials and even in

situations where pregnant women

require therapeutics, pharmacokinetic

studies are rarely done. There are many

reasons for this. Pregnancy is a

temporary condition and easily

forgotten in ‘‘wish lists’’ for data, by

subspecialists who treat pregnant

women with serious medical problems.

Also, interested investigators may be

reluctant to pursue pharmacokinetic

studies in pregnant women because of

their lack of knowledge related to

pregnancy or fetal development. Finally,

where information does exist in the

medical literature about

pharmacokinetics of individual drugs in

pregnancy, the data have rarely

appeared in product labels, creating

further disincentives for conducting

such clinical research. This latter reality

has its own set of probable causes, but

may change as FDA enhances

requirements for product safety updates

based on scientific literature and human

experience data. Regardless of the root

causes for the current paucity of

information, rational prescribing for the

pregnant patient must attempt to ensure

that she will have the greatest likelihood

of clinical benefit from a medication in

exchange for the safest or least exposure

of her developing baby. This can only be

achieved when adequate

pharmacokinetic dosing data are

available.

The agency hopes this meeting will

help summarize the state of knowledge

on clinical pharmacology in pregnancy,

raise awareness among clinician

researchers and leaders about the need

for clinical research and collaboration in

this area, and garner support for such

research from health advocacy groups

and others.