Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 54347 

soluble antigen, to a mucosal surface. 

The soluble antigens can be full length, 

naturally occurring polypeptides or 

fragments (i.e. peptides) derived from 

them. The soluble antigen is 

administered with an adjuvant at the 

mucosal site or without an adjuvant. 

Adjuvants can be, for example, Cholera 

toxin (CT), mutant CT (MCT), E. coli 

heat labile enterotoxin (LT) and others. 

Cytokines like IL–12 or IFNg can also be 

administered to enhance the 

immunoreactivity. Mucosal routes of 

administration include intrarectal (IR), 

intranasal (IN), intragastric (IG), 

intravaginal (IVG) or intratratracheal 

(IT). Soluble antigens can be derived 

from pathogenic viruses (e.g. HIV, 

influenza, or hepatitis virus), bacteria 

(e.g. Listeria monocytogenes), or 

prozoans. Furthermore, the soluble 

antigen can be tumor-associated antigen 

for cancer applications. 

The utility of the technology has been 

extensively demonstrated when applied 

to HIV. Details about the HIV studies are 

provided in the eight (8) publications 

cited below. 

Applications 

• Immunization to treat infectious 

diseases. 

• Possible applications in cancer 

therapy. 

Development Status: Proof of concept 

has been demonstrated, in particular as 

related to HIV. 

Inventors: Jay A. Berzofsky (NCI) et al. 

Relevant Publications 

1. Belyakov IM, Derby MA, Ahlers JD, 

Kelsall BL, Earl P, Moss B, Strober W, 

Berzofsky JA. Mucosal immunization 

with HIV–1 peptide vaccine induces 

mucosal and systemic cytotoxic T 

lymphocytes and protective immunity 

in mice against intrarectal recombinant 

HIV-vaccinia challenge. Proc Natl Acad 

Sci USA. 1998 Feb 17;95(4):1709–1714. 

[PubMed: 9465081] 

2. Belyakov IM, Ahlers, JD, 

Brandwein BY, Earl P, Kelsall B, Moss 

B, Strober W, Berzofsky JA. The 

importance of local mucosal HIVspecific CD8+ cytotoxic T lymphocytes 

for resistance to mucosal viral 

transmission in mice and enhancement 

of resistance by local administration of 

IL–12. J Clin Invest. 1998 Dec 

15;102(12):2072–2081. [PubMed: 

9854042] 

3. Belyakov IM, Ahlers JD, Clements 

JD, Strober W, Berzofsky JA. Interplay of 

cytokines and adjuvants in the 

regulation of mucosal and systemic HIVspecific CTL. J Immunol. 2000 Dec 

1;165(11):6454–6462. [PubMed: 

11086085] 

4. Belyakov IM, Hel Z, Kelsall B, 

Kuznetsov VA, Ahlers JD, Nacsa J, 

Watkins DI, Allen TM, Sette A, Altman 

J, Woodward R, Markham PD, Clements 

JD, Franchini G, Strober W, Berzofsky 

JA. Mucosal AIDS vaccine reduces 

disease and viral load in gut reservoir 

and blood after mucosal infection of 

macaques. Nat Med. 2001 

Dec;7(12):1320–1326. [PubMed: 

11726972] 

5. Belyakov IM, Kuznetsov VA, 

Kelsall B, Klinman D, Moniuszko M, 

Lemon M, Markham PD, Pal R, 

Clements JD, Lewis MG, Strober W, 

Franchini G, Berzofsky JA. Impact of 

vaccine-induced mucosal high avidity 

CD8+ CTLs in delay of AIDS-viral 

dissemination from mucosa. Blood 2006 

Apr 15;107(8):3258–3264. [PubMed: 

16373659] 

6. Belyakov IM, Isakov DV, Zhu Q, 

Dzutsev A, Berzofsky JA. A novel 

functional CTL avidity/activity 

compartmentalization to the site of 

mucosal immunization contributes to 

protection of macaques against simian/ 

human immunodeficiency viral 

depletion of mucosal CD4+ T cells. J 

Immunol. 2007 Jun 1;178(11):7211– 

7221. [PubMed: 17513770] 

7. Belyakov IM, Ahlers JD, Nabel GJ, 

Moss B, Berzofsky JA. Generation of 

functionally active HIV–1 specific CD8+ 

CTL in intestinal mucosa following 

mucosal, systemic, or mixed primeboost immunization. Virology 2008 Nov 

10;381(1):106–115. [PubMed: 18793787] 

8. Sui Y, Zhu Q, Gagnon S, Dzutsev 

A, Terabe M, Vaccari M, Venzon D, 

Klinman D, Strober W, Kelsall B, 

Franchini G, Belyakov IM, Berzofsky JA. 

Innate and adaptive immune correlates 

of vaccine and adjuvant-induced control 

of mucosal transmission of SIV in 

macaques. Proc Natl Acad Sci USA. 

2010 May 25;107(21):9843–9848. 

[PubMed: 20457926] 

Patent Status: HHS Reference No. E– 

268–1997/2— 

• U.S. Patent Application No. 09/ 

508,552, which issued as U.S. Patent 

No. 6,749,856 on 15 Jun 2004. 

• Foreign patents issued in Australia 

(Application Number 93862/98 and 

Patent Number 757310) and in 

European countries (Application 

Number 98946965.5 and Patent Number 

1011720): Germany, France, Ireland, 

United Kingdom, Italy, Portugal and 

Spain. 

• Divisional U.S. Patent Application 

No. 10/815,340 filed 30 Mar 2004. 

Licensing Status: Available for 

licensing and commercial development. 

Licensing Contacts: Uri Reichman, 

PhD, MBA; 301–435–4616; 

UR7a@nih.gov; or John Stansberry, PhD; 

301–435–5236; js852e@nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, Vaccine 

Branch, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize Mucosal Cytotoxic T 

Lymphocyte Responses. Please contact 

John D. Hewes, PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Dated: August 31, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–22182 Filed 9–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0426] 

Draft Guidance for Industry: Bar Code 

Label Requirements—Questions and 

Answers (Question 12 Update); 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Bar Code Label 

Requirements—Questions and Answers 

(Question 12 Update)’’ dated August 

2010. This draft guidance provides you, 

manufacturers of a licensed vaccine, 

with advice concerning compliance 

with the bar code label requirements. In 

this guidance, FDA is proposing to 

amend our response to question 12 

(Q12) in the ‘‘Bar Code Label 

Requirements—Questions and Answers’’ 

guidance dated October 2006 (Bar Code 

Guidance), to provide recommendations 

to manufacturers of licensed vaccines in 

connection with the use of alternative 

coding technologies. When this 

guidance is finalized, we intend to 

incorporate the revised response to Q12 

into the Bar Code Guidance, but 

otherwise continue with our 

recommendations for bar code label 

requirements as currently provided in 

the Bar Code Guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
54348 Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 

on the draft guidance by November 8, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin A. Chacko, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Bar Code Label 

Requirements—Questions and Answers 

(Question 12 Update)’’ dated August 

2010. FDA regulations require that 

certain human drug and biological 

product labels contain a bar code 

(§ 201.25 (21 CFR 201.25)). This draft 

guidance provides you, manufacturers 

of a licensed vaccine, with advice 

concerning compliance with the bar 

code label requirements. Previously, 

FDA issued questions and answers 

regarding how the bar code label 

requirements apply to specific products 

or circumstances in the Bar Code 

Guidance (October 5, 2006, 71 FR 

58739). In this guidance, FDA is 

proposing to amend our response to 

question 12 (Q12) in the Bar Code 

Guidance to provide recommendations 

to manufacturers of licensed vaccines in 

connection with the use of alternative 

coding technologies. We are revising our 

response because we believe that an 

alternative regulatory program, 

comprised of alternative technology 

such as two dimensional symbology, 

could render the use of linear bar codes 

unnecessary for patient safety and could 

enhance health care providers’ ability to 

comply with the National Childhood 

Vaccine Injury Act of 1986 (Public Law 

99–660) (42 U.S.C. 300aa-25(a))). We 

would consider granting a request for 

exemption to the bar code requirement 

under § 201.25(d)(ii) in connection with 

such use. 

II. Paperwork Reduction Act of 1995 

The draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

The collection of information in 21 CFR 

part 201 has been approved under OMB 

control number 0910–0537. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulations.gov. 

Dated: August 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22169 Filed 9–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings 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 Institute of 

Mental Health Special Emphasis Panel; ITVC 

Conflicts. 

Date: October 6, 2010. 

Time: 11 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. (Telephone 

Conference Call) 

Contact Person: Enid Light, PhD, Scientific 

Review Officer, Division of Extramural 

Activities, National Institute of Mental 

Health, NIH, Neuroscience Center, 6001 

Executive Boulevard, Room 6132, MSC 9608, 

Bethesda, MD 20852, 301–443–3599, 

elight@mail.nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel; K99. 

Date: October 18, 2010. 

Time: 11 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. (Telephone 

Conference Call) 

Contact Person: Megan Libbey, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6148, MSC 9609, 

Rockville, MD 20852–9609, 301–402–6807, 

libbeym@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: August 31, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22185 Filed 9–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1