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
59636 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.regulations.gov. 

Dated: October 1, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–24052 Filed 10–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Health Professions 

Student Loan (HPSL) Program and 

Nursing Student Loan (NSL) Program 

Administrative Requirements 

(Regulations and Policy) (OMB No. 

0915–0047)—Extension 

The regulations for the Health 

Professions Student Loan (HPSL) 

Program and Nursing Student Loan 

(NSL) Program contain a number of 

reporting and recordkeeping 

requirements for schools and loan 

applicants. The requirements are 

essential for assuring that borrowers are 

aware of rights and responsibilities, that 

schools know the history and status of 

each loan account, that schools pursue 

aggressive collection efforts to reduce 

default rates, and that they maintain 

adequate records for audit and 

assessment purposes. Schools are free to 

use improved information technology to 

manage the information required by the 

regulations. 

The annualized estimates of burden 

are as follows: 

RECORDKEEPING REQUIREMENTS

Regulatory/section requirements Number of 

recordkeepers Hours per year Total burden hours 

HPSL Program: 

57.206(b)(2), Documentation of Cost of Attendance ............................................. 432 1 .17 505 

57.208(a), Promissory Note ................................................................................... 432 1 .25 540 

57.210(b)(1)(i), Documentation of Entrance Interview ........................................... 432 1 .25 540 

57.210(b)(1)(ii), Documentation of Exit Interview ................................................... * 472 0 .33 156 

57.215(a)&(d), Program Records ........................................................................... * 472 10 4,720 

57.215(b), Student Records ................................................................................... * 472 10 4,720 

57.215(c), Repayment Records ............................................................................. * 472 18 .75 8,850 

HPSL Subtotal ................................................................................................. 472 .............................. 20,031 

NSL Program: 

57.306(b)(2)(ii), Documentation of Cost of Attendance ......................................... 300 0 .3 90 

57.308(a), Promissory Note ................................................................................... 300 0 .5 150 

57.310(b)(1)(i), Documentation of Entrance Interview ........................................... 300 0 .5 150 

57.310(b)(1)(ii), Documentation of Exit Interview ................................................... * 435 0 .17 74 

57.315(a)(1)&(a)(4), Program Records .................................................................. * 435 5 2,175 

57.315(a)(2), Student Records ............................................................................... * 435 1 435 

57.315(a)(3), Repayment Records ......................................................................... * 435 2 .51 1,092 

NSL Subtotal ................................................................................................... 435 .............................. 4,166 

* Includes active and closing schools. 

HPSL data includes active and closing Loans for Disadvantaged Students (LDS) program schools. 

REPORTING REQUIREMENTS

Regulatory/section requirements Number of 

respondents 

Responses per 

respondent 

Total annual 

responses 

Hours per 

response 

Total hour 

burden 

HPSL Program: 

57.206(a)(2), Student Financial Aid 

Transcript .......................................... 4,600 1 4,670 .25 1,150 

57.208(c), Loan Information Disclosure 432 68 .73 29,692 .0833 2,473 

57.210(b)(1)(i), Entrance Interview ....... 432 68 .73 29,692 0 .167 4,959 

57.210(b)(1)(ii), Exit Interview .............. * 472 12 5,664 0 .5 2,832 


sroberts on PROD1PC70 with NOTICES