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.