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.

Federal Register / Vol. 65, No. 193 / Wednesday, October 4, 2000 / Notices 59193

II. Registration

There is no registration fee, however

preregistration is required. Register

early, as space is limited. The meeting

room will hold approximately 250

people. Registration will begin with the

publication of this notice. If you will

need special accommodations due to a

disability to attend the meeting, please

inform the contact person listed above.

You may obtain information and register

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

cder/audiences/women/

pharmpreg2000.htm.

Dated: September 25, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–25386 Filed 10–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Privacy Act of 1974; Report of New

System

AGENCY: Health Care Financing,

Department of Health and Human

Services (HHS), Administration (HCFA).

ACTION: Notice of New System of

Records.

SUMMARY: In accordance with the

requirements of the Privacy Act of 1974,

we are proposing to establish a new

system of records, ‘‘Record of

Individuals Allowed Regular and

Special Parking Privileges at the HCFA

Building (PRKG), HHS/HCFA/OICS,

System No. 09–70–3004.’’ PRKG will be

used as part of our building security

plan. All Federal employees will be

issued parking permits by HCFA to

provide regular or special parking based

on specific needs.

The primary purpose of the system of

records is to issue parking permits for

the HCFA complex at 7500 Security

Boulevard, Baltimore, Maryland.

Information retrieved from this system

of records will also be used to support

regulatory and policy activities

performed within the agency or by a

contractor or consultant; support

constituent requests made to a

Congressional representative; and to

support litigation involving the agency

related to this system of records. We

have provided background information

about the proposed system in the

‘‘Supplementary Information’’ section

below. Although the Privacy Act

requires only that HCFA provide an

opportunity for interested persons to

comment on the proposed routine uses,

HCFA invites comments on all portions

of this notice. See ‘‘Effective Dates’’

section for comment period.

EFFECTIVE DATES: HCFA filed a new

system report with the Chair of the

House Committee on Government

Reform and Oversight, the Chair of the

Senate Committee on Governmental

Affairs, and the Administrator, Office of

Information and Regulatory Affairs,

Office of Management and Budget

(OMB) on September 20, 2000. To

ensure that all parties have adequate

time in which to comment, the new

system of records, including routine

uses, will become effective 40 days from

the publication of the notice, or from the

date it was submitted to OMB and the

Congress, whichever is later, unless

HCFA receives comments that require

alterations to this notice.

ADDRESSES: The public should address

comments to: Director, Division of Data

Liaison and Distribution (DDLD), HCFA,

Room N2–04–27, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850. Comments received will be

available for review at this location, by

appointment, during regular business

hours, Monday through Friday from 9

a.m.–3 p.m., eastern time zone.

FOR FURTHER INFORMATION CONTACT: Ms.

Kris Zaruba, Division of Facilities

Management Services, Administrative

Services Group, Office of Internal

Customer Support, HCFA, 7500 Security

Boulevard, SLL–11–08, Baltimore,

Maryland 21244–1850. The telephone

number is 410–786–0837.

SUPPLEMENTARY INFORMATION:

I. Description of the New System of

Records

Statutory and Regulatory Basis for

System of Records

HCFA proposes a new system of

records collecting data under the

authority of 5 U.S.C. 301.

II. Collection and Maintenance of Data

in the System.

A. Scope of the Data Collected

The collected information on all

HCFA employees and non-HCFA

employees who require parking

privileges at HCFA buildings, will

contain name, social security number,

parking permit number, telephone

number, work location, position, title

and grade, supervisor’s name and

telephone number and background

information relating to medical or

specific parking needs.

B. Agency Policies, Procedures, and

Restrictions on the Routine Use

The Privacy Act permits disclosure of

information without an individual’s

consent if the information is to be used

for a purpose, which is compatible with

the purpose(s) for which the

information was collected. Any such

disclosure of data is known as a

‘‘routine use.’’ The government will

only release PRKG information as

provided for under ‘‘Section III. Entities

Who May Receive Disclosures Under

Routine Use.’’

We will only disclose the minimum

personal data necessary to achieve the

purpose of PRKG. HCFA has the

following policies and procedures

concerning disclosures of information,

which will be maintained in the system.

In general, disclosure of information

from the system of records will be

approved only to the extent necessary to

accomplish the purpose of the

disclosure and only after HCFA:

(a) Determines that the use or

disclosure is consistent with the reason

data is being collected; e.g., implements

the regulations and directives that

established that Federal workers and

other authorized personnel will be

issued parking permits for the HCFA

complex.

(b) Determines:

(1) That the purpose for which the

disclosure is to be made can only be

accomplished if the record is provided

in individually identifiable form;

(2) That the purpose for which the

disclosure is to be made is of sufficient

importance to warrant the effect and/or

risk on the privacy of the individual that

additional exposure of the record might

bring; and

(3) That there is a strong probability

that the proposed use of the data would

in fact accomplish the stated purpose(s).

(c) Requires the information recipient

to:

(1) Establish administrative, technical,

and physical safeguards to prevent

unauthorized use of disclosure of the

record;

(2) Remove or destroy at the earliest

time all individually-identifiable

information; and

(3) Agree to not use or disclose the

information for any purpose other than

the stated purpose under which the

information was disclosed.

(d) Determines that the data are valid

and reliable.

III. Proposed Routine Use Disclosures

of Data in the System

Entities Who May Receive Disclosures

Under Routine Use

The routine use disclosures in this

system may occur only to the following