Federal Register / Vol. 65, No. 115 / Wednesday, June 14, 2000 / Notices 37395

C. Availability of Funds

Approximately $1,823,000 is available

in FY 2000 to fund one award. It is

expected that the award will begin on or

about September 30, 2000 and will be

made for a 12-month budget period

within a project period of up to three

years.

D. Where To Obtain Additional

Information

Business management technical

assistance may be obtained from: Van A.

King, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), Announcement [00098], 2920

Brandywine Road, Room 3000, Atlanta,

GA 30341, Telephone Number (770)

488–2751, Email Address

vbk5@cdc.gov.

Program technical assistance may be

obtained from: Earl Ford, Division of

Nutrition and Physical Activity,

National Center for Chronic Disease

Prevention and Health Promotion,

Centers for Disease Control and

Prevention (CDC), 4770 Buford

Highway, MS K–26, Atlanta, GA 30341–

3724, Telephone Number (770)488–

6015, Email Address EFord@cdc.gov.

Dated: June 8, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–14943 Filed 6–13–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00104]

National Tuberculosis Controllers

Association; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for the National Tuberculosis

Controllers Association (NTCA). This

program addresses the ‘‘Healthy People

2010’’, priority area of Immunization

and Infectious Diseases.

The purpose of this program is to: (1)

Maintain an effective communication

capacity among the nation’s

tuberculosis (TB) control officials (TB

Controllers) and TB nursing

professionals; (2) to sustain a capacity

for coordinating the rapid,

comprehensive assessment of problems

and opportunities in the field of TB

prevention and control; (3) to maintain

the capacity to coordinate the

consultations and collaborations that

produce a front line perspective on the

fast moving programmatic, scientific,

and technological issues affecting the

goal of TB elimination; (4) to assist in

identifying TB training needs; and (5) to

continue the capacity for cataloging and

tracking the public and private assets of

the nation’s TB elimination effort.

B. Eligible Applicants

Assistance will be provided only to

the National Tuberculosis Controllers

Association (NTCA). No other

applications are solicited.

NTCA is the only organization that

has an established relationship with

state and local health department TB

prevention and control programs, access

to TB Controllers and TB nursing

professionals, and expertise which is

necessary to carry out the project. NTCA

is a unique organization because of the

technical expertise of its members,

especially relating to its application

amidst the complex and changing

environment of front line health care

delivery.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $150,000 will be

available in FY 2000 to fund this award.

It is expected that the award will begin

on or about September 30, 2000, and

will be made for a 12-month budget

period within a project period of up to

5 years. Funding estimates may change.

Continuation awards within an

approved project will be made on the

basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements’’. An

application kit will be provided to

NTCA.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Carrie

Clark, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

Room 3000, 2920 Brandywine Road,

Atlanta, GA 30341–4146, Telephone:

(404) 488–2783, E-Mail Address:

zri4@cdc.gov.

For program technical assistance,

contact: John Seggerson, Office of the

Director, Division of Tuberculosis

Elimination, National Center for HIV,

STD, and TB Prevention, Mail Stop E–

10, Atlanta, GA 30333, Telephone: (404)

639–5328, E-Mail Address:

jjs1@cdc.gov.

Dated: June 8, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–14948 Filed 6–13–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel (SEP): Research To

Strengthen Occupational Safety and

Health Surveillance, RFA OH–00–005

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Disease, Disability, and Injury

Prevention and Control Special Emphasis

Panel (SEP): Research to Strengthen

Occupational Safety and Health Surveillance,

RFA OH–00–005.

Times and Dates:

9 a.m.–9:30 a.m., July 10, 2000 (Open).

9:30 a.m.–5 p.m., July 10, 2000 (Closed).

8 a.m.–Noon, July 11, 2000 (Closed).

Place: Embassy Suites, 1900 Diagonal

Road, Alexandria, Virginia 22314.

Status: Portions of the meeting will be

closed to the public in accordance with

provisions set forth in section 552b(c)(4) and

(6), Title 5 U.S.C., and the Determination of

the Associate Director for Management and

Operations, CDC, pursuant to Public Law 92–

463.

Matters to be Discussed: The meeting will

include the review, discussion, and

evaluation of applications received in

response to RFA–OH–00–005.

Contact Person for More Information:

Michael J. Galvin, Jr., Ph.D., Health Science

Administrator, Centers for Disease Control

and Prevention, National Institute for

Occupational Safety and Health, 1600 Clifton

Road, N.E., m/s D30 Atlanta, Georgia 30333.

Telephone 404/639–3525, e-mail

mtg3@cdc.gov.

37396 Federal Register / Vol. 65, No. 115 / Wednesday, June 14, 2000 / Notices

The Director, Management Analysis and

Services office has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities, for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: June 8, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–14947 Filed 6–13–00; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1307]

Draft Guidance for Industry on

Development of Parathyroid Hormone

for the Prevention and Treatment of

Osteoporosis; Availability

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 ‘‘Development of

Parathyroid Hormone for the Prevention

and Treatment of Osteoporosis.’’

Parathyroid hormone (PTH) is being

studied for use in the prevention and

treatment of osteoporosis. In response to

preclinical studies submitted to FDA in

which osteosarcomas developed in rats

and mice following administration of

PTH and related peptides, the agency is

developing guidance for the

development of PTH as a drug for

osteoporosis. This guidance is intended

to improve the benefit to risk ratio of

treatment with PTH and related

peptides.

DATES: Submit written comments on the

draft guidance by August 14, 2000.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Copies of this draft

guidance for industry are available on

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

guidance/index.htm. Submit written

requests for single copies of the draft

guidance to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Eric

Colman, Center for Drug Evaluation and

Research (HFD–510), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6371.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled

‘‘Development of Parathyroid Hormone

for the Prevention and Treatment of

Osteoporosis.’’ This draft guidance is

being issued in response to information

submitted to the agency regarding the

development of osteosarcomas in two

strains of rats and one strain of mice

following treatment with PTH and

related peptides from weaning to 18

months. Given the uncertain clinical

relevance of the findings in rodents, and

in an effort to improve the benefit to risk

ratio of PTH when used in studies of the

prevention and/or treatment of

osteoporosis, the draft guidance

recommends that special consideration

be given to the design and conduct of

clinical trials evaluating the safety and

effectiveness of PTH. These special

considerations relate to inclusion and

exclusion criteria, patient followup, and

patient informed consent.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). The draft guidance represents the

agency’s current thinking on the

development of parathyroid hormone in

the prevention and treatment of

osteoporosis. 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,

regulations, or both.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any 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

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: June 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–14986 Filed 6–13–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review:

Comment Request: National Institute

of Diabetes and Digestive and Kidney

Diseases Information Clearinghouses

Customer Satisfaction Survey

SUMMARY: Under the provisions of

Section 3507(a)(1)(D) of the Paperwork

Reduction Act of 1995, the National

Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK), the National

Institutes of Health (NIH), has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on January 19, 2000, pages

2967–1968 and allowed 60 days for

public comment. No public comments

were received. The purpose of this

notice is to allow an additional 30 days

for public comment. The National

Institutes of Health may not conduct or

sponsor, and the respondent is not

required to respond to, an information

collection that has been extended,

revised, or implemented on or after

October 1, 1995, unless it displays a

currently valid OMB control number.

Proposed Collection

Title: NIDDK Information

Clearinghouses Customer Satisfaction

Survey. Type of Information Request:

NEW. Need and Use of Information

Collection: NIDDK will conduct a

survey to evaluate the efficiency and

effectiveness of services provided its

three information clearinghouses:

National Diabetes Information

Clearinghouse, National Digestive

Diseases Information Clearinghouse,

National Kidney and Urologic Diseases

Information Clearinghouse. The survey

responds to Executive Order 12862,

‘‘Setting Customer Services Standards,’’

which requires agencies and

departments to identify and ‘‘survey

their customers to determine the kind

and quality of service they want and

their level of satisfaction with existing

service.’’ Frequency of Response: On

occasion. Affected Public: Individuals or

households; clinics or doctor’s offices.

Type of Respondents: Physicians,

nurses, patients, family.

The annual reporting burden is as

follows: Estimated Number of

Respondents: 12,000; Estimated Number

of Responses per Respondent: 1;

Estimated Average Burden Hours Per

Response: 0.1671; and Estimated Total

Annual Burden Hours Requested: 2,000.