Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices 19225 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Linda 

Wisniewski, Office of Clinical Research 

Training and Medical Education, 

Clinical Center, Building 10, Room: 

1N252B, 9000 Rockville Pike, Bethesda, 

MD 20892, or call 301–496–9425 or 

E-mail your request, including your 

address to: wisniewskil@cc.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: April 16, 2009. 

Laura Lee, 

Project Clearance Liaison, Warren Grant 

Magnuson Clinical Center, National Institutes 

of Health. 

[FR Doc. E9–9688 Filed 4–27–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0565] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution; Appeals Above the 

Division Level 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 28, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0396. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Formal 

Dispute Resolution; Appeals Above the 

Division Level—(OMB Control Number 

0910–0396)—Extension 

This information collection approval 

request is for an FDA guidance on the 

process for formally resolving scientific 

and procedural disputes in the Center 

for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER) that 

cannot be resolved at the division level. 

The guidance describes procedures for 

formally appealing such disputes to the 

office or center level and for submitting 

information to assist center officials in 

resolving the issue(s) presented. The 

guidance provides information on how 

the agency will interpret and apply 

provisions of the existing regulations 

regarding internal agency review of 

decisions (§ 10.75) and dispute 

resolution during the investigational 

new drug (IND) process (§ 312.48) and 

the new drug application/abbreviated 

new drug application (NDA/ANDA) 

process (§ 314.103). In addition, the 

guidance provides information on how 

the agency will interpret and apply the 

specific Prescription Drug User Fee Act 

(PDUFA) goals for major dispute 

resolution associated with the 

development and review of PDUFA 

products. 

Existing regulations, which appear 

primarily in parts 10, 312, and 314 (21 

CFR parts 10, 312, and 314), establish 

procedures for the resolution of 

scientific and procedural disputes 

between interested persons and the 

agency, CDER, and CBER. All agency 

decisions on such matters are based on 

information in the administrative file 

(§ 10.75(d)). In general, the information 

in an administrative file is collected 

under existing regulations in parts 312 

(OMB Control No. 0910–0014), 314 

(OMB Control No. 0910–0001), and part 

601 (21 CFR part 601) (OMB Control No. 

0910–0338), which specify the 

information that manufacturers must 

submit so that FDA may properly 

evaluate the safety and effectiveness of 

drugs and biological products. This 

information is usually submitted as part 

of an IND, NDA, or biologics license 

application (BLA), or as a supplement to 

an approved application. While FDA 

already possesses in the administrative 

file the information that would form the 

basis of a decision on a matter in 

dispute resolution, the submission of 

particular information regarding the 

request itself and the data and 

information relied on by the requestor 

in the appeal would facilitate timely 

resolution of the dispute. The guidance 

describes the following collection of 

information not expressly specified 

under existing regulations: The 

submission of the request for dispute 

resolution as an amendment to the 

application for the underlying product, 

including the submission of supporting 

information with the request for dispute 

resolution. 

Agency regulations (§§ 312.23(11)(d), 

314.50, 314.94, and 601.2) state that 

information provided to the agency as 

part of an IND, NDA, ANDA, or BLA is 

to be submitted in triplicate and with an 

appropriate cover form. Form FDA 1571 

must accompany submissions under 

INDs and Form FDA 356h must 

accompany submissions under NDAs, 

ANDAs, and BLAs. Both forms have 

valid OMB control numbers as follows: 

FDA Form 1571—OMB Control No. 

0910–0014, and FDA Form 356h—OMB 

Control No. 0910–0338. 

In the guidance document, CDER and 

CBER ask that a request for formal 

dispute resolution be submitted as an 

amendment to the application for the 

underlying product and that it be 

submitted to the agency in triplicate 

with the appropriate form attached, 

either Form FDA 1571 or Form FDA 

356h. The agency recommends that a 

request be submitted as an amendment 

in this manner for two reasons: To 

ensure that each request is kept in the 

administrative file with the entire 

underlying application and to ensure 

that pertinent information about the 

request is entered into the appropriate 

tracking databases. Use of the 

information in the agency’s tracking 

databases enables the appropriate 

agency official to monitor progress on 

the resolution of the dispute and to 


erowe on PROD1PC64 with NOTICES
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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