27790 Federal Register / Vol. 75, No. 95 / Tuesday, May 18, 2010 / Notices 

There are no Capital Costs, Operating 

costs, and/or Maintenance Costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Ms. Liz Elliott, 

NIGMS, NIH, Natcher Building, Room 

2AN–18H, 45 Center Drive, MSC 6200, 

Bethesda, MD 20892–6200, or call nontoll-free number 301–594–2755 or email your request, including your 

address to: elliotte@nigms.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: May 10, 2010. 

Sally Lee, 

Executive Officer, National Institute of 

General Medical Sciences, National Institutes 

of Health. 

[FR Doc. 2010–11857 Filed 5–17–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0057] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on How to Submit Information 

in Electronic Format to the Center for 

Veterinary Medicine Using the FDA 

Electronic Submission Gateway 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 17, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0454. Also 

include the FDA docket number found 

in brackets in the heading of this 

document 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., P150– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on How to 

Submit Information in Electronic 

Format to the Center for Veterinary 

Medicine Using the FDA Electronic 

Submission Gateway (OMB Control 

Number 0910–0454)—Extension 

The Center for Veterinary Medicine 

(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. 

In the Federal Register of February 5, 

2010 (75 FR 6038), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/Form 3538 No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Respondent 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 January 1, 2008, and December 31, 2008. 

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: May 12, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11808 Filed 5–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

mstockstill on DSKH9S0YB1PROD with NOTICES