8970 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

TABLE 2.—ESTIMATED RECORDKEEPING BURDEN1—Continued 

Number of 

Recordkeepers 

Number of Records 

per Recordkeeping Total Records Hours per Record Total Hours 

Total 90 

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

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3980 Filed 2–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0391] 

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 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 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: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), 1401 Rockville Pike, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist that 

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. 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: 

Marla Stevens-Riley, Center for Drug 

Evaluation and Research (HFD– 

600), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276– 

9310, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852, 301–827– 

6210; 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 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 guidance addresses the 

information that should be submitted in 

an NDA, ANDA, NADA, ANADA, or 

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. FDA 

conducts scientific evaluation of the 

parametric release program as part of a 

cooperative effort between FDA product 

reviewers and the compliance program. 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8971 

On August 5, 2008 (73 FR 45454), 

FDA announced the availability of the 

draft version of this guidance. The 

public comment period closed on 

October 6, 2008. A number of comments 

were received, which the agency 

considered carefully as it finalized the 

guidance and made appropriate 

changes. Most of the changes to the 

guidance were made to clarify 

statements in the draft guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the agency’s 

current thinking on inclusion of 

recommended 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 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 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3978 Filed 2–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel, NEI K99 Grant 

Applications. 

Date: March 1, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Hotel—Chevy Chase 

Pavilion Washington, DC 20015. 

Contact Person: Daniel R. Kenshalo, PhD, 

Scientific Review Officer, National Eye 

Institute, National Institutes of Health, 5635 

Fishers Lane, Suite 1300, MSC 9300, 

Bethesda, MD 20892, 301–451–2020, 

kenshalod@nei.nih.gov. 

This Notice is late due to administrative 

procedures. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: February 17 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–3784 Filed 2–25–10; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1514–N] 

Medicare Program; Public Meetings in 

Calendar Year 2010 for All New Public 

Requests for Revisions to the 

Healthcare Common Procedure Coding 

System (HCPCS) Coding and Payment 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

dates, time, and location of the 

Healthcare Common Procedure Coding 

System (HCPCS) public meetings to be 

held in calendar year 2010 to discuss 

our preliminary coding and payment 

determinations for all new public 

requests for revisions to the HCPCS. 

These meetings provide a forum for 

interested parties to make oral 

presentations or to submit written 

comments in response to preliminary 

coding and payment determinations. 

Discussion will be directed toward 

responses to our specific preliminary 

recommendations and will include all 

items on the public meeting agenda. 

DATES: Meeting Dates: The following are 

the 2010 HCPCS public meeting dates: 

1. Tuesday, May 4, 2010, 9 a.m. to 5 

p.m., eastern daylight time (e.d.t.) 

(Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

2. Wednesday, May 5, 2010, 9 a.m. to 

5 p.m., e.d.t. (Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

3. Tuesday, May 25, 2010, 9 a.m. to 

5 p.m., e.d.t. (Supplies and Other). 

4. Wednesday, May 26, 2010, 9 a.m. 

to 5 p.m., e.d.t. (Supplies and Other). 

5. Thursday, May 27, 2010, 9 a.m. to 

5 p.m, e.d.t. (Orthotics and Prosthetics). 

6. Tuesday, June 8, 2010, 9 a.m. to 5 

p.m., e.d.t. (Durable Medical Equipment 

(DME) and Accessories). 

Deadlines for Primary Speaker 

Registration and Presentation Materials: 

The deadline for registering to be a 

primary speaker, and submitting 

materials and writings that will be used 

in support of an oral presentation are as 

follows: 

• April 20, 2010 for the May 4 and 5, 

2010 public meetings. 

• May 11, 2010 for the May 25, 26 

and 27, 2010 public meetings. 

• May 25, 2010 for the June 8, 2010 

public meeting. 

Deadline for Attendees that are 

Foreign Nationals (reside outside the 


sroberts on DSKD5P82C1PROD with NOTICES