9028 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or http:// 

www.regulations.gov. 

Dated: February 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3474 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0520] 

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 document entitled 

‘‘Guidance for Industry: Potency Tests 

for Cellular and Gene Therapy Products’’ 

dated January 2011. The 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 that 

could support an investigational new 

drug application (IND) or a biologics 

license application (BLA). The guidance 

announced in this notice finalizes the 

draft guidance of the same title dated 

October 2008. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the 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 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 guidance 

document. 

Submit electronic comments on the 

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: 

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 document entitled ‘‘Guidance for 

Industry: Potency Tests for Cellular and 

Gene Therapy Products’’ dated January 

2011. The guidance document provides 

manufacturers of cellular and gene 

therapy 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 acceptance 

criteria for product release. 

In the Federal Register of October 9, 

2008 (73 FR 59635), FDA announced the 

availability of the draft guidance of the 

same title. FDA received several 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. A summary of 

changes includes the addition of text 

related to adjuvant testing and 

modification of assay parameters for 

validation studies. In addition, editorial 

and formatting changes were made to 

improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated October 2008. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents 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 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This 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; the collections of 

information in 21 CFR part 312 has been 

approved under 0910–0014; the 

collections of information in 21 CFR 

part 601 has been approved under 

0910–0338. 

III. Comments 

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 guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: February 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3462 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0069] 

Training Program for Regulatory 

Project Managers; Information 

Available to Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) Center for Drug 

Evaluation and Research (CDER) is 

announcing the continuation of the 

Regulatory Project Management Site 

Tours and Regulatory Interaction 

Program (the Site Tours Program). The 

purpose of this document is to invite 

pharmaceutical companies interested in 

participating in this program to contact 

CDER. 

DATES: Pharmaceutical companies may 

submit proposed agendas to the Agency 

by April 18, 2011. 

FOR FURTHER INFORMATION CONTACT: Beth 

Duvall-Miller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6466, 

Silver Spring, MD 20993–0002, 301– 

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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 9029 

796–0700, e-mail: 

elizabeth.duvallmiller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

An important part of CDER’s 

commitment to make safe and effective 

drugs available to all Americans is 

optimizing the efficiency and quality of 

the drug review process. To support this 

primary goal, CDER has initiated 

various training and development 

programs to promote high performance 

in its regulatory project management 

staff. CDER seeks to significantly 

enhance review efficiency and review 

quality by providing the staff with a 

better understanding of the 

pharmaceutical industry and its 

operations. To this end, CDER is 

continuing its training program to give 

regulatory project managers the 

opportunity to tour pharmaceutical 

facilities. The goals are to provide the 

following: (1) Firsthand exposure to 

industry’s drug development processes 

and (2) a venue for sharing information 

about project management procedures 

(but not drug-specific information) with 

industry representatives. 

II. The Site Tours Program 

In this program, over a 2- to 3-day 

period, small groups (five or less) of 

regulatory project managers, including a 

senior level regulatory project manager, 

can observe operations of 

pharmaceutical manufacturing and/or 

packaging facilities, pathology/ 

toxicology laboratories, and regulatory 

affairs operations. Neither this tour nor 

any part of the program is intended as 

a mechanism to inspect, assess, judge, 

or perform a regulatory function, but is 

meant rather to improve mutual 

understanding and to provide an avenue 

for open dialogue. During the Site Tours 

Program, regulatory project managers 

will also participate in daily workshops 

with their industry counterparts, 

focusing on selective regulatory issues 

important to both CDER staff and 

industry. The primary objective of the 

daily workshops is to learn about the 

team approach to drug development, 

including drug discovery, preclinical 

evaluation, tracking mechanisms, and 

regulatory submission operations. The 

overall benefit to regulatory project 

managers will be exposure to project 

management, team techniques, and 

processes employed by the 

pharmaceutical industry. By 

participating in this program, the 

regulatory project manager will grow 

professionally by gaining a better 

understanding of industry processes and 

procedures. 

III. Site Selection 

All travel expenses associated with 

the site tours will be the responsibility 

of CDER; therefore, selection will be 

based on the availability of funds and 

resources for each fiscal year. Selection 

will also be based on firms having a 

favorable facility status as determined 

by FDA’s Office of Regulatory Affairs 

District Offices in the firms’ respective 

regions. Firms interested in offering a 

site tour or learning more about this 

training opportunity should respond by 

submitting a proposed agenda to Beth 

Duvall-Miller (see DATES and FOR

FURTHER INFORMATION CONTACT). 

Dated: February 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3461 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB), under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Ryan White HIV/ 

AIDS Program Core Medical Services 

Waiver Application Requirements 

(OMB No. 0915–0307)—Extension 

Title XXVI, Section 2671 of the Public 

Health Service (PHS) Act, as amended 

by the Ryan White HIV/AIDS Treatment 

Extension Act of 2009 (Ryan White HIV/ 

AIDS Program), requires that grantees 

expend 75 percent of Parts A, B, and C 

Funds on core medical services, 

including antiretroviral drugs for 

individuals with HIV/AIDS, identified 

and eligible under the legislation. In 

order for Grantees under Parts A, B, and 

C to be exempted from the 75 percent 

core medical services requirement, they 

must request and receive a waiver from 

HRSA, as required in the Act. 

HRSA utilizes standards for granting 

waivers of the core medical services 

requirement for the Ryan White HIV/ 

AIDS Program. These standards meet 

the intent of the Ryan White HIV/AIDS 

Program to increase access to core 

medical services, including 

antiretroviral drugs for persons with 

HIV/AIDS, and to ensure that grantees 

receiving waivers demonstrate the 

availability of such services for 

individuals with HIV/AIDS, identified 

and eligible under Title XXVI of the 

PHS Act. The core medical services 

waiver uniform standard and waiver 

request process will apply to Ryan 

White HIV/AIDS Program Grant Awards 

under Parts A, B, and C of Title XXVI 

of the PHS Act. Core medical services 

waivers will be effective for a 1-year 

period that is consistent with the grant 

award period. 

Grantees must submit a waiver 

request with the annual grant 

application containing the certifications 

and documentation which will be 

utilized by HRSA in making 

determinations regarding waiver 

requests. Grantees must provide 

evidence that all of the core medical 

services listed in the statute, regardless 

of whether such services are funded by 

the Ryan White HIV/AIDS Program, are 

available to all individuals with HIV/ 

AIDS, identified and eligible under Title 

XXVI of the PHS Act in the service area 

within 30 days. 

The annual estimate of burden is as 

follows: 

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