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on the draft guidance by November 8, 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single copies of the draft guidance to the 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The draft guidance may also be obtained 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electronic access to the draft guidance 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draft guidance to http:// 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
Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 54349 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

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 on 

Drug Abuse Special Emphasis Panel, NIDA 

Clinical Science Conference Grant (R13) 

Review. 

Date: September 29, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852. 

(Virtual Meeting) 

Contact Person: Gerald L. McLaughlin, 

PhD, Scientific Review Administrator, Office 

of Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Blvd., Bethesda, MD 

20892–8401. 301–402–6626. 

gm145a@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel, NIDA 

B/Start Small Grant Review. 

Date: October 20, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852. 

(Virtual Meeting) 

Contact Person: Gerald L. McLaughlin, 

PhD, Scientific Review Administrator, Office 

of Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Blvd., Bethesda, MD 

20892–8401. 301–402–6626. 

gm145a@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Initial Review Group, Training 

and Career Development Subcommittee. 

Date: November 3–5, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ritz-Carlton Hotel, 1150 22nd Street, 

NW., Rockville, MD 20852, Washington, DC 

20037. 

Contact Person: Kristen V. Huntley, PhD, 

Scientific Review Administrator, Office of 

Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Boulevard, Bethesda, 

MD 20892–8401. 301–435–1433. 

huntleyk@mail.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel, NIDA 

I/Start Small Grant Review. 

Date: November 10, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852. 

(Virtual Meeting.) 

Contact Person: Gerald L. McLaughlin, 

PhD, Scientific Review Administrator, Office 

of Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Blvd., Bethesda, MD 

20892–8401. 301–402–6626. 

gm145a@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: August 31, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22183 Filed 9–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Negotiated Rulemaking Committee on 

Designation of Medically Underserved 

Populations and Health Professional 

Shortage Areas; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Negotiated Rulemaking 

Committee on Designation of Medically 

Underserved Populations and Health 

Professional Shortage Areas. 

Date and time: September 22, 2010, 

9:30 a.m. to 5 p.m. 

September 23, 2010, 9 a.m. to 4:30 

p.m. 

September 24, 2010, 9 a.m. to12 p.m. 

Place: The Legacy Hotel, Georgetown 

Room, 1775 Rockville Pike, Rockville, 

Maryland 20852, (301) 881–2300. 

Status: The meeting will be open to 

the public. 

Purpose: The purpose of the 

Negotiated Rulemaking Committee on 

Designation of Medically Underserved 

Populations and Health Professional 

Shortage Areas is to establish a 

comprehensive methodology and 

criteria for Designation of Medically 

Underserved Populations and Primary 

Care Health Professional Shortage 

Areas, using a Negotiated Rulemaking 

(NR) process. It is hoped that use of the 

NR process will yield a consensus 

among technical experts and 

stakeholders on a new rule, which will 

then be published as an Interim Final 

Rule in accordance with Section 5602 of 

Public Law 111–148, the Patient 

Protection and Affordable Care Act of 

2010. 

Agenda: The meeting will be held on 

Wednesday, September 22, Thursday, 

September 23 and Friday, September 24, 

and will include an orientation to the 

negotiated rulemaking process, ground 

rules for Committee operations, and an 

overview of the key topics on which the 

Committee will explore and seek 

consensus. The Friday morning meeting 

will include development of the agenda 

for the next meeting, as well as an 

opportunity for public comment. 

FOR FURTHER INFORMATION CONTACT: For 

more information, please contact Lauren 

Krantz, Office of Shortage Designation, 

Bureau of Health Professions, Health 

Resources and Services Administration, 

Room 9A–18, Parklawn Building, 5600 

Fishers Lane, Rockville, Maryland 

20857, Telephone (301) 443–9027, Email lkrantz@hrsa.gov, or visit http:// 

bhpr.hrsa.gov/shortage/. 

SUPPLEMENTARY INFORMATION: Requests 

from the public to make oral comments 

or to provide written comments to the 

Committee should be sent to Lauren 

Krantz at the contact address above at 

least 10 days prior to the meeting. The 

meetings will be open to the public as 

indicated below, with attendance 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

Contact Person listed above at least 10 

days prior to the meeting. Members of 

the public will have the opportunity to 

provide comments at the Friday 

morning meeting. 

Dated: September 1, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–22194 Filed 9–3–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0007] 

Animal Models—Essential Elements To 

Address Efficacy Under the Animal 

Rule; Notice of Public Meeting; and 

Reopening of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; and 

reopening of comment period. 

SUMMARY: The Food and Drug 

Administration’s (FDA or agency) 

Center for Biologics Evaluation and 

Research (CBER) and Center for Drug 

Evaluation and Research (CDER) are 

announcing a public meeting to solicit 

comments and concerns of industry, 

other government agencies, and 

interested parties on the regulatory and 

scientific challenges as addressed in the 

draft document entitled ‘‘Guidance for 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1