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Draft Guidance for Industry on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availability of a draft guidance for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draft guidance by August 14, 2000.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.

Federal Register / Vol. 65, No. 115 / Wednesday, June 14, 2000 / Notices 37397

The annualized cost to respondents is

estimated at $39,000. There are no

Capital Costs to report. There are no

Operating or Maintenance Costs to

report.

Type of respondents Number of respondents

Frequency of

response

Estimated average response timeEstimated annual burden

hours

Patients/Family ................................................................................................ 3,600 1.0 0.167 600

Phys. Asst ........................................................................................................ 7,200 1.0 0.167 1,200

Physicians ........................................................................................................ 1,200 1.0 0.167 200

Totals ........................................................................................................ 12,000 ........................ ........................ 2,000

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection techniques of

other forms of information technology.

Direct Comments to OMB

Written comments and/or suggestions

regarding the item(s) contained in this

notice, especially regarding the

estimated public burden and associated

response time, should be directed to the:

Office of Management and Budget,

Office of Regulatory Affairs, New

Executive Office Building, Room 10235,

Washington, DC 20503, Attention: Desk

Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact: Kathy

Kranzfelder, Project Officer, NIDDK

Information Clearinghouses, NIH,

Building 31, Room 9A04, MSC2560,

Bethesda, MD 20852, or call non-tollfree number (301) 435–8113 or E-mail

your request, including your address, to:

kranzfeldk@hq.niddk.nih.gov

Comments Due Date

Comments regarding this information

are best assured of having their full

effect if received within 30 days

following the date of this publication.

Dated: May 25, 2000.

L. Earl Laurence,

Executive Officer, NIDDK.

[FR Doc. 00–14956 Filed 6–13–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute Special Emphasis Panel, NCI

Transition Career Development Award (K22

applications).

Date: June 16, 2000.

Time: 4:00 PM to 8:00 PM.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn—Georgetown, 2101

Wisconsin Avenue, N.W., Washington, DC

20007.

Contact Person: Mary Bell, Scientific

Review Administrator, Grants Review

Branch, Division of Extramural Activities,

National Cancer Institute, National Institutes

of Health, 6116 Executive Boulevard, Room

8058, Bethesda, MD 20892.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology

Research; 93.397, Cancer Centers Support;

93.398, Cancer Research Manpower; 93.399,

Cancer control, National Institutes of Health,

HHS)

Dated: June 6, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–14962 Filed 6–13–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institute of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the meeting of the

Board of Scientific Counselors, National

Cancer Institute.

The meeting will be closed to the

public as indicated below in accordance

with the provisions set forth in sections

552b(c)(6) and 552b(c)(9)(B), Title 5

U.S.C., as amended. The discussions

could reveal information of a personal

nature where disclosure would

constitute a clearly unwarranted

invasion of personal privacy and the

premature disclosure of discussions

related to personnel and programmatic

issues would be likely to significantly

frustrate the subsequent implementation

of recommendations.

Name of Committee: Board of Scientific

Counselors, National Cancer Institute,

Subcommittee B—Basic Sciences.

Date: July 10, 2000.

Time: 8:00 AM to 5:30 PM.

Agenda: Chair’s Remarks; Division

Director’s Report and Discussion of

personnel and programmatic issues; Site

Visit Reports; Review and evalaute

individual Principal Investogators.

Place: National Cancer Institute, Building

31, C Wing, 6th Floor, Conference Room 6,

9000 Rockville Pike, Bethesda, MD 20892.