Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45453 

the order. In addition, the order enables 

the Commission to seek civil penalties 

against Respondent for non-compliance 

with the order. 

The proposed Consent Agreement 

further requires McCormick to maintain 

the viability of the assets identified for 

divestiture. Among other requirements 

related to maintaining operations of the 

assets, the proposed Consent Agreement 

requires McCormick to: (1) maintain the 

viability, competitiveness, and 

marketability of the assets to be 

divested; (2) not cause the wasting or 

deterioration of the assets to be 

divested; (3) not sell, transfer, 

encumber, or otherwise impair the 

assets’ marketability or viability; (4) 

maintain the assets consistent with past 

practices; (5) use best efforts to preserve 

the assets’ existing relationships with 

suppliers, customers, and employees; 

and (6) keep and maintain the assets at 

inventory levels consistent with past 

practices. 

The proposed Consent Agreement 

prohibits McCormick, for ten (10) years, 

from acquiring, without providing the 

Commission with prior notice, any other 

seasoned salt product, or any interest in 

any other spice blends business. The 

provisions regarding prior notice are 

consistent with prior Orders. The 

proposed Consent Agreement does not 

restrict McCormick from expanding its 

line of spices. 

McCormick is required to file 

compliance reports with the 

Commission, the first of which is due 

within thirty (30) days of the date on 

which Respondent signed the proposed 

Consent Agreement, and every thirty 

(30) days thereafter until the 

divestitures are completed, and 

annually for ten (10) years. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed Consent Agreement, and it is 

not intended to constitute an official 

interpretation of the proposed Decision 

and Order and the Order to Maintain 

Assets, or to modify their terms in any 

way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary of the Commission. 

[FR Doc. E8–17868 Filed 8–4–08: 8:45 am] 

[BILLING CODE 6750–01–S] 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Impact of Cultural 

and Socioeconomic Factors on PostTreatment Surveillance Among African 

Americans With Colorectal Cancer, 

Potential Extramural Project 2008–R–

03 

Notice of Cancellation: This notice 

was published in the Federal Register 

on July 22, 2008, Volume 73, Number 

141, page 42576. The meeting 

previously scheduled to convene on 

August 6, 2008 has been cancelled. 

Contact Person for More Information: 

Linda Shelton, Program Specialist, 

Coordinating Center for Health and 

Information Service, Office of the 

Director, Centers for Disease Control 

and Prevention, 1600 Clifton Road, NE., 

MS E21, Atlanta, GA 30333, Telephone 

(404) 498–1194. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: July 28, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–17913 Filed 8–4–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request Proposed 

Projects 

Title: Compassion Capital Fund 

Impact Evaluation. 

OMB No.: 0970–0293. 

Description: This proposed 

information collection activity is an 

extension of the follow-up survey of 

faith-based and community 

organizations participating in the 

Compassion Capital Fund (CCF) Impact 

Evaluation. The currently approved 

information collection will expire on 

December 31, 2008. This information 

collection request will include the 

agency’s request for an extension of the 

initial survey instruments for an 

additional three years. 

The CCF evaluation is an important 

opportunity to examine the 

effectiveness of the Compassion Capital 

Fund Demonstration program in 

meeting its objective of improving the 

capacity of faith-based and community 

organizations. The evaluation includes 

selected CCF-funded intermediary 

organizations that provide capacitybuilding services and the faith-based 

and community organizations that 

sought those services. The follow-up 

survey will be used to collect 

information from the faith-based and 

community based organizations on 

various areas of organizational capacity. 

The study design includes the random 

assignment of faith based and 

community organizations to either a 

treatment group that receives capacitybuilding services from a CCF 

intermediary grantee or to a control 

group that does not. The impact of the 

services provided by intermediaries, 

primarily through sub-awards and/or 

technical assistance (TA), will be 

determined by comparing the changes 

reported through the survey in 

organizational and service capacity of 

the recipient organizations with those of 

the control group. 

Respondents: Faith-based and 

community organizations included in 

the CCF impact evaluation. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Follow-up Survey ............................................................................................. 455 1 .42 191 

Estimated Total Annual Burden Hours: ........................................................... ........................ ........................ ........................ 191 


dwashington3 on PRODPC61 with NOTICES
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