Federal Register / Vol. 63, No. 86 /Tuesday, May 5, 1998 / Notices 24813

presentations from the public will be

scheduled between approximately 9

a.m. and 9:15 a.m., and between

approximately 3:30 p.m. and 3:45 p.m.,

on May 26, 1998, and between

approximately 9 a.m. and 9:15 a.m., and

between approximately 1:30 p.m. and

1:45 p.m., and between approximately

3:30 p.m. and 3:45 p.m., on May 27,

1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before May 19, 1998, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

May 26 and 27, 1998, from 8 a.m. to 9

a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). These portions of

the meeting will be closed to discuss

pending investigational new drug

applications or pending product

licensing applications.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 28, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–11806 Filed 5–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0149]

Guidance for Industry on National

Uniformity for Nonprescription

Drugs—Ingredient Listing for OTC

Drugs; Availability; Clarification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; clarification.

SUMMARY: The Food and Drug

Administration (FDA) is clarifying an

administrative error relating to a notice

that appeared in the Federal Register of

April 9, 1998 (63 FR 17429). The notice

announced the availability of a guidance

for industry entitled ‘‘National

Uniformity for Nonprescription Drugs—

Ingredient Listing for OTC Drugs.’’ The

agency displayed the incorrect draft of

the guidance. This document clarifies

that error.

FOR FURTHER INFORMATION CONTACT:

Thomas C. Kuchenberg, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 9, 1998 (63 FR

17429), FDA published a notice

announcing the availability of a

guidance for industry entitled ‘‘National

Uniformity for Nonprescription Drugs—

Ingredient Listing for OTC Drugs.’’ The

agency, however, inadvertently put on

display a working draft of the guidance

dated February 1998, rather than the

version the agency intends to

implement, which is dated April 1998.

This notice clarifies that error by

announcing the availability of the April

1998 version of the guidance document

and by withdrawing the February 1998

draft. Additionally, on February 19,

1998, FDA inadvertently put the

working draft dated February 1998 on

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

guidance/index.htm. The agency

intends to replace the working draft that

is on the Internet with the April 1998

version in the near future.

Dated: April 27, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–11841 Filed 5–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; Responsibility of Applicants

for Promoting Objectivity in Research

for Which Public Health Service (PHS)

Funding is Sought

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

Office of the Director (OD), the National

Institutes of Health (NIH) will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection

Title: Responsibility of Applicants for

Promoting Objectivity in Research for

Which Public Health Service (PHS)

Funding is Sought: 42 CFR Part 50; 45

CFR Part 94. Type of Information

Collection Request: Extension of OMB

No. 0925–0417, expiration date 09/30/

98. Need and Use of Information

Collection: This is a request for OMB

approval for the information collection

and recordkeeping requirements

contained in the final rule 42 CFR Part

50 and 45 CFR Part 94. The purpose of

the regulations is to protect the

objectivity with which PHS-funded

research is conducted. The regulations

require disclosure of financial interests

related to PHS-funded research by

personnel who have decision-making

responsibilities that could affect the

outcome of the research. Frequency of

Response: On occasion. Affected Public:

Individuals or households; Business or

other for-profit; Not-for-profit

institutions; State, Local or Tribal

Government. Type of Respondents: Any

public or private entity or organization.

The annual reporting burden is as

follows: Estimated Number of

Respondents: 57,235; Estimated Number

of Responses per Respondent: 10;

Average Burden Hours per Response:

20; and Estimated Total Annual Burden

Hours Requested: 171,110. The

annualized costs to respondents is

estimated at: $5,068,850. There are no

Capital Costs, Operating Costs and/or

Maintenance Costs to report.

Request For Comments

Written comments and/or suggestions

from the public and affected agencies

should address one or more of the

following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and

clarity of the information to be

collected; and (4) 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 or other forms of

information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact: Thomas F.

McCormack, Ph.D., Assistant Grant’s

Policy Officer, Office of Extramural

Research, Office of Policy for

Extramural Research Administration,

6701 Rockledge Drive, Bethesda, MD

20892, or call non-toll-free number (301)

435–0935 or E-mail your request,