6038 Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices 

Guidance for Industry on How to 

Submit a Notice of Final Disposition of 

Investigational Animals Not Intended 

for Immediate Slaughter in Electronic 

Format to the Center for Veterinary 

Medicine—21 CFR 514.117(b)(2) and 21 

CFR 511.1(b)(5); (OMB Control Number 

0910–0453)—Extension 

The Center for Veterinary Medicine 

(CVM) monitors the final disposition of 

investigational animals where such 

animals do not enter the human food 

chain immediately at the completion of 

an investigational study. CVM’s 

monitoring of the final disposition of 

investigational food animals is intended 

to ensure that unsafe residues of new 

animal drugs do not get into the food 

supply. CVM issues a slaughter 

authorization letter to investigational 

new animal drug (INAD) sponsors that 

sets the terms under which 

investigational animals may be 

slaughtered (21 CFR 511.1(b)(5)). Also 

in the letter, CVM requests that sponsors 

submit a notice of final disposition of 

investigational animals (NFDA) not 

intended for immediate slaughter. 

NFDAs have historically been submitted 

to CVM on paper. CVM’s guidance 

entitled ‘‘How to Submit a Notice of 

Final Disposition of Investigational 

Animals Not Intended for Immediate 

Slaughter in Electronic Format to CVM,’’ 

provides sponsors with an option to 

submit an NFDA as an e-mail 

attachment to CVM via the Internet. 

The likely respondents are INAD 

sponsors. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/Form No. 3487 No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

511.1(b)(5) 40 0.4 16 .08 1.3 

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

2Electronic submissions received between January 1, 2008, and December 31, 2008. 

The number of respondents in table 1 

of this document are the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between January 1, 

2008, and December 31, 2008. Thus, 

FDA estimates the total reporting 

burden at 1.3 hours (16 x .08 = 1.3 total 

hours). 

Dated: January 29, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2527 Filed 2–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0057] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on How to Submit Information 

in Electronic Format to the Center for 

Veterinary Medicine Using the Food 

and Drug Administration Electronic 

Submission Gateway 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting requirements for the 

Center for Veterinary Medicine’s 

(CVM’s) ‘‘Guidance for Industry on How 

to Submit Information in Electronic 

Format to the Center for Veterinary 

Medicine Using the FDA Electronic 

Gateway.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by April 6, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of management and budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices 6039 

Guidance for Industry on How to 

Submit Information in Electronic 

Format to the Center for Veterinary 

Medicine Using the FDA Electronic 

Submission Gateway—21 CFR 11.2 

(OMB Control Number 0910–0454)— 

Extension) 

CVM accepts certain types of 

submissions electronically with no 

requirement for a paper copy. These 

types of documents are listed in public 

docket 97S–0251 as required by 21 CFR 

11.2. CVM’s ability to receive and 

process information submitted 

electronically is limited by its current 

information technology capabilities and 

the requirements of the Electronic 

Records; Electronic Signatures final 

regulation. CVM’s guidance entitled 

‘‘Guidance for Industry: How to Submit 

Information in Electronic Format to 

CVM Using the FDA Electronic 

Submission Gateway’’ outlines general 

standards to be used for the submission 

of any information by e-mail. 

The likely respondents are sponsors 

for new animal drug applications. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/FDA Form 3538 No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

11.2 40 1.3 52 .08 4.2 

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

2Electronic submissions received between July 1, 2005, and June 30, 2006. 

The number of respondents in table 1 

of this document is the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between January 1, 

2008 and December 31, 2008, (52 x 

hours per response (.08) =4.2 total 

hours). 

Dated: January 29, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2523 Filed 2–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; 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 Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel Training. 

Date: March 1, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Peter Kozel, PhD, 

Scientific Review Officer, NCCAM, 6707 

Democracy Boulevard, Suite 401, Bethesda, 

MD 20892–5475, 301–496–8004, 

kozelp@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: January 29, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–2557 Filed 2–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; 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 Institute of 

Biomedical Imaging and Bioengineering 

Special; 2010/05 SBIR Review. 

Date: March 11, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Gaylord National Hotel & 

Convention Center, 201 Waterfront Street, 

National Harbor, MD 20745. 

Contact Person: John K. Hayes, PhD, 

Scientific Review Officer, 6707 Democracy 

Boulevard, Suite 959, Democracy Two, 

Bethesda, MD 20892, 301–451–3398, 

hayesj@mail.nih.gov. 

Dated: February 1, 2010 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–2562 Filed 2–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Neurodevices, Bioengineering and 

Biomodeling. 

Date: February 24, 2010. 


srobinson on DSKHWCL6B1PROD with NOTICES