19226 Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices 

ensure that appropriate steps will be 

taken in a timely manner. 

CDER and CBER have determined and 

the guidance recommends that the 

following information should be 

submitted to the appropriate center with 

each request for dispute resolution so 

that the center may quickly and 

efficiently respond to the request: (1) A 

brief but comprehensive statement of 

each issue to be resolved, including a 

description of the issue, the nature of 

the issue (i.e., scientific, procedural, or 

both), possible solutions based on 

information in the administrative file, 

whether informal dispute resolution 

was sought prior to the formal appeal, 

whether advisory committee review is 

sought, and the expected outcome; (2) a 

statement identifying the review 

division/office that issued the original 

decision on the matter and, if 

applicable, the last agency official that 

attempted to formally resolve the 

matter; (3) a list of documents in the 

administrative file, or additional copies 

of such documents, that are deemed 

necessary for resolution of the issue(s); 

and (4) a statement that the previous 

supervisory level has already had the 

opportunity to review all of the material 

relied on for dispute resolution. The 

information that the agency suggests 

submitting with a formal request for 

dispute resolution consists of: (1) 

Statements describing the issue from the 

perspective of the person with a 

dispute, (2) brief statements describing 

the history of the matter, and (3) the 

documents previously submitted to FDA 

under an OMB approved collection of 

information. 

Based on FDA’s experience with 

dispute resolution, the agency expects 

that most persons seeking formal 

dispute resolution will have gathered 

the materials listed previously when 

identifying the existence of a dispute 

with the agency. Consequently, FDA 

anticipates that the collection of 

information attributed solely to the 

guidance will be minimal. 

Description of Respondents: A 

sponsor, applicant, or manufacturer of a 

drug or biological product regulated by 

the agency under the Federal Food, 

Drug, and Cosmetic Act or section 351 

of the Public Health Service Act who 

requests formal resolution of a scientific 

or procedural dispute. 

Burden Estimate: Provided in table 1 

of this document is an estimate of the 

annual reporting burden for requests for 

dispute resolution. Based on data 

collected from review divisions and 

offices within CDER and CBER, FDA 

estimates that approximately 13 

sponsors and applicants (respondents) 

submit requests for formal dispute 

resolution to CDER annually and 

approximately 1 respondent submits 

requests for formal dispute resolution to 

CBER annually. The total annual 

responses are the total number of 

requests submitted to CDER and CBER 

in 1 year, including requests for dispute 

resolution that a single respondent 

submits more than one time. FDA 

estimates that CDER receives 

approximately 22 requests annually and 

CBER receives approximately 1 request 

annually. The hours per response is the 

estimated number of hours that a 

respondent would spend preparing the 

information to be submitted with a 

request for formal dispute resolution in 

accordance with this guidance, 

including the time it takes to gather and 

copy brief statements describing the 

issue from the perspective of the person 

with the dispute, brief statements 

describing the history of the matter, and 

supporting information that has already 

been submitted to the agency. Based on 

experience, FDA estimates that 

approximately 8 hours on average 

would be needed per response. 

Therefore, FDA estimates that 184 hours 

will be spent per year by respondents 

requesting formal dispute resolution 

under the guidance. 

In the Federal Register of November 

3, 2008 (73 FR 65385), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Requests for Formal Dispute 

Resolution 

No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

CDER 13 1.7 22 8 176 

CBER 1 1 1 8 8 

Total 184 

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

Dated: April 21, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9632 Filed 4–27–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Cellular, Tissue and Gene Therapies 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Cellular, Tissue and 

Gene Therapies Advisory Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on May 14, 2009, from 8 a.m. to 

approximately 6 p.m. and on May 15, 2009, 

from 8 a.m. to approximately 1 pm. 

Location: Hilton Hotel, Grand Ballroom, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: Gail Dapolito or Danielle 

Cubbage, Food and Drug Administration, 

1401 Rockville Pike (HFM–71), Rockville, 

MD, 301–827–0314, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington, DC 

area), code 3014512389. Please call the 

Information Line for up-to-date information 

on this meeting. A notice in the Federal 

Register about last minute modifications that 

impact a previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide timely 

notice. Therefore, you should always check 

the agency’s Web site and call the 

appropriate advisory committee hot line/ 

phone line to learn about possible 

modifications before coming to the meeting. 

Agenda: On May 14 in the morning, in 

open session, the Committee will discuss the 

potential for Chlamydia trachomatis and 

Neisseria gonorrhea transmission by human 

cells, tissues, and cellular and tissue-based 


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Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices 19227 

products (HCT/Ps) that are recovered from 

the reproductive system or gestational tissues 

(e.g., amnionic membrane and placenta, cells 

recovered from menstrual blood, foreskin, 

placental/umbilical cord blood derived cell 

products), or other sources. In the afternoon, 

in open session, the Committee will discuss 

animal models for porcine 

xenotransplantation products intended to 

treat Type 1 diabetes or acute liver failure. 

On May 15, in open session, the Committee 

will: (1) Receive an update on Guidance 

documents from the Office of Cellular, Tissue 

and Gene Therapies, Center for Biologics 

Evaluation and Research and the Center for 

Veterinary Medicine and (2) discuss clinical 

issues related to the FDA draft guidance 

‘‘Preparation of IDEs and INDs for Products 

Intended to Repair or Replace Knee 

Cartilage.’’ 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http:// 

www.fda.gov/ohrms/dockets/ac/acmenu.htm, 

click on the year 2009 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before May 

7, 2009. Oral presentations from the public 

will be scheduled on May 14 between 

approximately 11 a.m. and 11:20 a.m. and 

between approximately 2 p.m. and 2:20 p.m. 

and on May 15 between approximately 10 

a.m. and 10:20 a.m. Those desiring to make 

formal oral presentations should notify the 

contact person 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 on or 

before May 6, 2009. Time allotted for each 

presentation may be limited. If the number of 

registrants requesting to speak is greater than 

can be reasonably accommodated during the 

scheduled open public hearing session, FDA 

may conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by May 7, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact Gail 

Dapolito at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/oc/ 

advisory/default.htm for procedures on 

public conduct during advisory committee 

meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: April 17, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–9592 Filed 4–27–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

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 

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 

Neurological Disorders and Stroke Special 

Emphasis Panel; Loan Repayment Program. 

Date: April 30, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Joann McConnell, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

Msc 9529, Bethesda, MD 20892–9529, (301) 

496–5324, mcconnej@ninds.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: April 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–9691 Filed 4–27–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

National Advisory Neurological 

Disorders and Stroke Council. 

The meeting 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 below 

in advance of the 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 

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 Advisory 

Neurological Disorders and Stroke Council; 

Training, Career Development, and Special 

Programs Subcommittee. 

Date: May 27, 2009. 

Open: 8 p.m. to 9:30 p.m. 

Agenda: To discuss the training plan of the 

institute. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Closed: 9:30 p.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Stephen J. Korn, PhD, 

Training and Special Programs Officer, 

National Institute of Neurological Disorders 

and Stroke, National Institutes of Health, 

6001 Executive Blvd., Suite 2154, MSC 9527, 

Bethesda, MD 20892–9527, (301) 496–4188. 

Information is also available on the 

Institute’s/Center’s home page: 

www.ninds.nih.gov, where an agenda and 


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