45454 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. E-mail address: 

OPREinfocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on (a) whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

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. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: July 29, 2008. 

Brendan C. Kelly, 

OPRE Reports Clearance Officer. 

[FR Doc. E8–17721 Filed 8–4–08; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0391] 

Draft Guidance for Industry on 

Submission of Documentation in 

Applications for Parametric Release of 

Human and Veterinary Drug Products 

Terminally Sterilized by Moist Heat 

Processes; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Submission of 

Documentation in Applications for 

Parametric Release of Human and 

Veterinary Drug Products Terminally 

Sterilized by Moist Heat Processes.’’

This draft guidance provides 

recommendations to applicants on 

information to include in support of 

parametric release for sterile products 

terminally sterilized by moist heat when 

submitting a new drug application 

(NDA), abbreviated new drug 

application (ANDA), new animal drug 

application (NADA), abbreviated new 

animal drug application (ANADA), or 

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 October 6, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, 7519 Standish 

Pl., Rockville, MD 20855; the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, 1401 Rockville Pike, 

Rockville, MD 20852–1448. The draft 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Marla Stevens-Riley, Center for Drug 

Evaluation and Research (HFD–

600), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–

9310; 

Deborah Trout, Center for Biologics 

Evaluation and Research (HFM–

675), Food and Drug 

Administration, 8800 Rockville 

Pike, Rockville, MD 20892, 301–

827–3031; or 

Mai Huynh, Center for Veterinary 

Medicine (HFV–142), Food and 

Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276–

8273. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Submission of Documentation in 

Applications for Parametric Release of 

Human and Veterinary Drug Products 

Terminally Sterilized by Moist Heat 

Processes.’’ The draft guidance 

addresses the information that should 

be submitted in an approved new drug 

application (NDA), abbreviated new 

drug application (ANDA), new animal 

drug application (NADA), abbreviated 

new animal drug application (ANADA), 

or biologics license application (BLA) in 

support of parametric release for sterile 

products terminally sterilized by moist 

heat. 

‘‘Parametric release’’ is defined as a 

sterility assurance release program 

where demonstrated control of the 

sterilization process enables a firm to 

use defined critical process controls, in 

lieu of the sterility test, to fulfill the 

intent of 21 CFR 211.167(a). Under this 

strategy, market release of terminally 

sterilized products can be based upon 

meeting the defined sterilization 

parameters and not on performing an 

approved sterility test. Meeting the 

requirements of the parametric release 

process can provide greater assurance 

that a batch meets the sterility 

requirement than can be achieved with 

a sterility test of finished units drawn 

from the batch. 

Parametric release allows 

manufacturers to replace sterility testing 

of samples drawn from the finished 

product as a release criterion with 

acceptance criteria for the control of 

identified process parameters. 

Parametric release of the batch is then 

based on documented evidence of the 

control of critical parameters, removing 

the need for testing of samples drawn 

from the finished product. 

An application to FDA is required to 

obtain approval for parametric release. 

The approval of parametric release is 

based on an assessment of the 

applicant’s proposed critical process 

parameters and how they are controlled. 

Demonstrated reliability of the 

production terminal sterilization cycle, 

microbiological control and monitoring, 

and control of production cycle 

parameters within established validated 

limits is part of this assessment. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on inclusion of recommended 


dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45455 

information to support applications for 

parametric release of human and 

veterinary drug products terminally 

sterilized by moist heat processes. 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 draft guidance contains 

information collection provisions that 

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 collection of 

information requested in the draft 

guidance is covered under FDA 

regulations at 21 CFR 314.50, 314.70, 

and 314.81(b)(2) for human drugs, 21 

CFR 514.1, 514.8, 514.8(b)(4) and (c) for 

animal drugs, and 21 CFR 601.2 and 

601.12 for biologics. The collection of 

information is approved under the 

following OMB control numbers: 0910–

0001 for human drugs, 0910–0600 for 

animal drugs, and 0910–0338 for 

biologics. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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 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. 

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 and 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 document at http:// 

www.fda.gov/cder/guidance/index.htm, 

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

guidelines.htm, or http:// 

www.regulations.gov. 

Dated: July 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17855 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0417] 

Draft Guidance for the Public and the 

Food and Drug Administration Staff on 

Convening Advisory Committee 

Meetings; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance 

document entitled ‘‘Guidance for the 

Public and FDA Staff on Convening 

Advisory Committee Meetings.’’ This 

draft guidance is intended to provide 

guidance on when FDA should consider 

referring a matter to an advisory 

committee. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing the availability of four 

guidances intended to improve FDA’s 

advisory committee procedures. 

DATES: Although you can comment on 

any guidance at any time (see 

§ 10.115(g)(5) (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 

October 6, 2008. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit phone requests to 800–835–4709 

or 301–827–1800. Submit written 

comments on the 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 . See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Jill 

Hartzler Warner, Office of Policy and 

Planning (HF–11), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3370. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Guidance for 

the Public and FDA Staff on Convening 

Advisory Committee Meetings,’’ dated 

July 2008. Advisory committees provide 

FDA with independent, expert advice 

on a range of complex scientific and 

technical issues related to the products 

it regulates. These issues typically focus 

on a specific food or medical product, 

a class of foods or medical products, the 

development and implementation of a 

specific regulatory program, or the 

development and implementation of a 

regulatory policy. Advisory committee 

meetings also facilitate public 

discussion of important topics and 

provide a means for the public to 

provide comments to the agency. 

To enhance the transparency of FDA’s 

advisory committee program, the agency 

is publishing this draft guidance to 

provide its current thinking on when to 

bring a matter to an advisory committee. 

In some instances, FDA refers a matter 

to an advisory committee because it is 

required to do so by law. In others, FDA 

convenes an advisory committee 

meeting at its own discretion. 

Regardless, FDA recognizes that 

advisory committee meetings demand 

significant resource commitments by 

advisory committee members, sponsors, 

and other public participants, as well as 

for FDA itself, and should be used for 

important matters. The draft guidance is 

intended to clarify how the agency 

identifies which matters should be 

referred. 

In developing this draft guidance, 

FDA has been mindful of the legal 

requirements of the Federal Advisory 

Committee Act (FACA), other relevant 

statutes, regulations, guidance, and 

policies, and the goals of FDA’s of 

advisory committee program. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The draft 

guidance represents the agency’s current 

thinking on when FDA convenes an 

advisory committee meeting. 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. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 


dwashington3 on PRODPC61 with NOTICES