65432 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Notices

product receives marketing exclusivity,

FDA will not approve (or, in limited

cases, even receive) an ANDA for the

drug product during that time period.

Respondents to this collection of

information are new drug and

abbreviated new drug applicants.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

314.50(i) 8 1 8 2 16

314.50(j) 50 1 50 2 100

314.52 8 1 8 8 64

314.53 200 1 200 1 200

314.54(a)(1)(vii) 8 1 8 1 8

314.70(f) 43 1 43 1 43

314.94(a)(12) 395 1 395 2 790

314.95 30 1 30 16 480

314.107(c)(4), (e)(2)(iv), (f)(2), (f)(3) 30 1 30 1 30

Total 1,731

1There are no capital costs or operating and maintenance costs associated with this collection of information.

This estimate is based on FDA’s

experience over the last 3 years in

receiving this information, and the

familiarity by FDA reviewers with the

amount of time it takes to prepare and

submit the information to FDA.

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32553 Filed 12–11–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0320]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Filing Objections and Requests for a

Hearing on a Regulation or Order’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA).

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 6, 1997 (62

FR 42257 to 42258), the agency

announced that the proposed

information collection had been

submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0184. The

approval expires on September 30,

2000.

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32583 Filed 12–11–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0443]

Iron-Containing Supplements and

Drugs: Label Warning Statements and

Unit-Dose Packaging Requirements;

Small Entity Compliance Guide;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a small entity compliance

guide entitled ‘‘Iron-Containing

Supplements and Drugs: Label Warning

Statements and Unit-Dose Packaging

Requirements; Small Entity Compliance

Guide’’ (compliance guide). This

compliance guide is intended to help

small entities comply with the final rule

requiring label warnings and unit-dose

packaging for iron-containing

supplements and drug products. This

action is being taken under the Small

Business Regulatory Enforcement

Fairness Act of 1996 (the SBREFA).

DATES: Written comments on the

compliance guide may be submitted at

any time.

ADDRESSES: An electronic version of the

compliance guide entitled ‘‘IronContaining Supplements and Drugs:

Label Warning Statements and UnitDose Packaging Requirements; Small

Entity Compliance Guide’’ is available

on the Internet at ‘‘http://

vm.cfsan.fda.gov/∼dms/secqiron.html’’.

Printed copies may be obtained from the

Iron Labeling and Packaging, Industry

Activities Staff (HFS–565), Center for

Food Safety and Applied Nutrition,

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204. Submit

written comments on the compliance

guide to the contact person below.

FOR FURTHER INFORMATION CONTACT:

Linda S. Kahl, Center for Food Safety

and Applied Nutrition (HFS–206), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3101.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 15, 1997 (62

FR 2218), FDA issued a final rule

requiring: (1) Label warning statements

on products taken in solid oral dosage

form to supplement the dietary intake of

iron or to provide iron for therapeutic

purposes and (2) unit-dose packaging

for iron-containing products that

contain 30 milligrams or more of iron

per dosage unit. This final rule became

effective July 15, 1997.
Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Notices 65433

FDA is announcing the availability of

a compliance guide entitled ‘‘IronContaining Supplements and Drugs:

Label Warning Statements and UnitDose Packaging Requirements; Small

Entity Compliance Guide’’ under the

SBREFA (Pub. L. 104–121). This

compliance guide is intended to help

small businesses comply with the

requirements of the new rule, and it

restates in plain language the legal

requirements set forth in the current

regulation for labeling and packaging of

iron-containing supplements and drug

products. Any statement in this

compliance guide that goes beyond

merely restating the applicable legal

requirements represents the agency’s

current thinking on this subject. The

regulation is binding and has the force

and effect of law; however, this

compliance guide does not, itself, 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 statute

and regulations.

Dated: November 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32552 Filed 12–11–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Allergy and

Infectious Diseases; 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

National Institute of Allergy and

Infectious Diseases Special Emphasis

Panel (SEP) meeting:

Name of SEP: Acute Infection and Early

Disease Research Network (AIEDRN).

Date: January 9, 1998.

Time: 8:00 a.m. to Adjournment.

Place: Holiday Inn Chevy Chase, 5520

Wisconsin Avenue, Chevy Chase, MD 20815,

(301) 656–1500.

Contact Person: Dr. Allen C. Stoolmiller,

Scientific Review Adm., 6003 Executive

Boulevard, Solar Bldg., Room 4C05,

Bethesda, MD 20892, (301) 496–7966.

Purpose/Agenda: To evaluate contract

proposals.

The meeting will be closed in accordance

with the provisions set forth in secs.

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

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.855, Immunology, Allergic

and Immunologic Diseases Research; 93.856,

Microbiology and Infectious Diseases

Research, National Institutes of Health.)

Dated: December 5, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–32470 Filed 12–11–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Promotion of Homologous

Recombination DNA Pairing by RecA

And RecA Peptides

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This notice is accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(I) that the National Institutes

of Health (NIH), Department of Health

and Human Services, is contemplating

the grant of an exclusive world-wide

license to practice the inventions

embodied in U.S. Patents No. 5,460,941,

entitled, ‘‘Method of Targeting DNA’’

and 5,510,473, entitled, ‘‘Cloning of the

RecA Gene From Thermus Aquaticus

YT–1’’, U.S. Patent Applications Serial

Numbers 08/446,413, entitled, ‘‘Cloning

of the RecA Gene From Thermus

Aquaticus YT–1’’, 08/483,115 entitled,

‘‘Promotion of Homologous

Recombination DNA Pairing By Rec-ADerived Peptides’’, 60/001,384 and 08/

682,305, ‘‘Rec A Assisted Cloning of

DNA’’, and corresponding U.S. and

foreign patent applications to the

Pangene Corporation of Menlo Park,

California. The patent rights in these

inventions have been assigned to the

United States of America.

DATES: Only written comments and/or

applications for a license which are

received by NIH on or before February

10, 1998 will be considered.

ADDRESSES: Requests for copies of the

patent applications, inquiries,

comments and other materials relating

to the contemplated licenses should be

directed to: Raphe Kantor, Ph.D.,

Technology Licensing Specialist, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804. Telephone: (301)

496–7735 ext. 247; Facsimile: (301)

402–0220. A signed Confidentially

Agreement will be required to receive

copies of the patent applications.

SUPPLEMENTARY INFORMATION: This

technology covers methodology for

inducing sequence-specific homologous

recombination between an exogenous

DNA sequence and the corresponding

genomic DNA sequence by use of the E.

coli RecA protein. The RecA protein

brings together an exogenous DNA

sequence and a corresponding genomic

DNA sequences for homologous

recombination. A peptide of RecA can

be substituted for the entire E. Coli RecA

protein to target a double-strand of DNA

or to inhibit transcription of a given

gene. The ability of a RecA peptide to

induce homologous recombination gives

this technology broad commercial

applicability. The peptide can be used

in site-specific targeting of DNA

sequences for purposes of cleavage,

protection or enrichment as a research

reagent, a diagnostic tool or for use in

gene therapy.

The prospective exclusive license will

be royalty-bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

exclusive license may be granted unless

within sixty (60) days from the date of

this published notice, NIH receives

written evidence and argument that

establishes that the grant of the license

would not be consistent with the

requirements of 35 U.S.C. 209 and 37

CFR 404.7.

The field of use of this exclusive

license may be limited to human

therapeutics.

Applications for a license filed in

response to this notice will be treated as

objections to the grant of the

contemplated licenses. Comments and

objections submitted to this notice will

not be available for public inspection

and, to the extent permitted by law, will

not be released under the Freedom of

Information Act, 5 U.S.C. 552.

Dated: December 1, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–32469 Filed 12–11–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–62]

Submission for OMB Review:

Comment Request

AGENCY: Office of Administration, HUD.