59634 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 

estimates the total annual industry 

burden to collect and provide the 

previous information to 216,600 burden 

hours. 

Table 1 of this document is a 

summary of the estimated annual 

burden hours for recalling firms 

(manufacturers, processors, and 

distributors) to comply with the 

voluntary reporting requirements of 

FDA’s recall regulations. 

In the Federal Register of June 3, 2008 

(73 FR 31696), FDA published a 60-day 

notice requesting public comment on 

the information collection provisions. 

No comments were received. 

Recognizing that there may be a vast 

difference in the information collection 

and reporting time involved in different 

recalls of FDA’s regulated products, 

FDA estimates on average the burden of 

collection for recall information to be as 

follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Recall strategy 7.42 2,166 1 2,166 20 43,320 

Firm initiated recall and recall communications 7.46 and 7.49 2,166 1 2,166 30 64,980 

Recall status reports and followup 

7.53 2,166 4 8,664 10 86,640 

Termination of a recall 7.55(b) 2,166 1 2,166 10 21,660 

Total 216,600 

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

The annual reporting burdens are 

explained as follows: 

Reporting 

A. Recall Strategy 

Request firms develop a recall strategy 

including provision for public warnings 

and effectiveness checks. Under this 

portion of the collection of information, 

the agency estimates it will receive 

2,166 responses annually. 

B. Firm Initiated Recall and Recall 

Communications 

Request firms voluntarily remove or 

correct foods and drugs (human or 

animal), cosmetics, medical devices, 

and biologicals to immediately notify 

the appropriate FDA district office of 

such actions. The firm is to provide 

complete details of the recall reason, 

risk evaluation, quantity produced, 

distribution information, firms’ recall 

strategy and a contact official as well as 

requires firms to notify their direct 

accounts of the recall and to provide 

recipients with a ready means of 

reporting to the recalling firm. Under 

these portions of the collection of 

information, the agency estimates it will 

receive 2,166 responses annually for 

each. 

C. Recall Status Reports 

Request that recalling firms provide 

periodic status reports so FDA can 

ascertain the progress of the recall. This 

collection of information will generate 

approximately 8,664 responses 

annually. 

D. Termination of a Recall 

Provide the firms an opportunity to 

request in writing that FDA end the 

recall. The agency estimates it will 

receive 2,166 responses annually. 

Dated: October 1, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23910 Filed 10–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Science Board to the Food and Drug 

Administration; 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: Science Board to 

the Food and Drug Administration 

(Science Board). 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex and 

technical issues as well as emerging 

issues within the scientific community 

in industry and academia. Additionally, 

the Science Board provides advice to 

the agency on keeping pace with 

technical and scientific evolutions in 

the fields of regulatory science, on 

formulating an appropriate research 

agenda, and on upgrading its scientific 

and research facilities to keep pace with 

these changes. It will also provide the 

means for critical review of agency 

sponsored intramural and extramural 

scientific research programs. 

Date and Time: The meeting will be 

held on Friday, October 31, 2008, from 

8 a.m. to 3:30 p.m. 

Location: Hilton, Washington DC 

North/Gaithersburg Hilton, 620 Perry 

Pkwy., Gaithersburg, MD 20877. 

Contact Person: Carlos Pen ̃ a, Office of 

the Commissioner, Food and Drug 

Administration (HF–33), 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

6687, carlos.pen ̃ a@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512603. 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: The Science Board will hear 

about and discuss a review of the draft 

assessment of Bisphenol A (BPA) for use 

in food contact applications by the 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 59635 

Science Board BPA Subcommittee. The 

Science Board will discuss 2009 agenda 

topics. The Science Board will also hear 

an overview of current methods for 

detection of contaminants in FDAregulated products. 

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 2008 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 October 24, 2008. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.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 October 16, 2008. 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 

October 17, 2008. 

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 Carlos Pen ̃ a 

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: October 3, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24051 Filed 10–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0520] 

Draft Guidance for Industry: Potency 

Tests for Cellular and Gene Therapy 

Products; 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: Potency Tests 

for Cellular and Gene Therapy 

Products’’ dated October 2008. The draft 

guidance document provides 

manufacturers of cellular and gene 

therapy (CGT) products with 

recommendations for developing tests to 

measure potency. The recommendations 

are intended to clarify the potency 

information needed to support an 

Investigational New Drug Application 

(IND) or a Biologics License Application 

(BLA). 

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 

written or electronic comments on the 

draft guidance by January 7, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (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 written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, 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: Potency Tests for Cellular and 

Gene Therapy Products’’ dated October 

2008. The draft guidance document 

provides manufacturers of CGT 

products with recommendations for 

developing tests to measure potency. 

The recommendations are intended to 

clarify the potency information needed 

to support an IND or a BLA. Because 

potency measurements are designed 

specifically for a particular product, the 

guidance does not make 

recommendations regarding specific 

types of potency assays, nor does it 

propose criteria for product release. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

The draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 211 has 

been approved under 0910–0139, 

expiration date September 20, 2008; the 

collections of information in 21 CFR 

part 312 has been approved under 

0910–0014, expiration date May 31, 

2009; the collections of information in 

21 CFR part 601 has been approved 

under 0910–0338, expiration date June 

30, 2010. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 


sroberts on PROD1PC70 with NOTICES