6034 Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices 

Dated: February 2, 2010. 

Jamison Citron, 

Special Assistant, Office of Faith-Based and 

Neighborhood Partnerships. 

[FR Doc. 2010–2577 Filed 2–4–10; 8:45 am] 

BILLING CODE 4154–07–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0035] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on How to Submit a Notice of 

Intent to Slaughter for Human Food 

Purposes in Electronic Format to the 

Center for Veterinary Medicine 

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 

information collection on how to submit 

a notice of intent to slaughter for human 

food purposes in electronic format to 

the Center for Veterinary Medicine 

(CVM). 

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 Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 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. 

Guidance for Industry on How to 

Submit a Notice of Intent to Slaughter 

for Human Food Purposes in Electronic 

Format to the Center for Veterinary 

Medicine—Section 512(j) of the Federal 

Food, Drug, and Cosmetic Act (OMB 

Control Number 0910–0450)—Extension 

Section 512(j) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360b(j)) gives FDA the authority 

to set conditions under which animals 

treated with investigational new animal 

drugs may be marketed for food use. 

Under this authority, CVM issues to a 

new animal drug sponsor (sponsors) a 

slaughter authorization letter that sets 

the terms under which investigational 

animals may be slaughtered. The U.S. 

Department of Agriculture (USDA),also 

monitors the slaughter of animals 

treated with investigational new animal 

drugs under the authority of the Meat 

Inspection Act (21 U.S.C. 601–695). 

Sponsors must submit slaughter notices 

each time investigational animals are 

presented for slaughter, unless this 

requirement is waived by an 

authorization letter (21 CFR 511.1(b)(5) 

and 9 CFR 309.17). These notifications 

assist CVM and USDA in monitoring the 

safety of the food supply. Slaughter 

notices were previously submitted to 

CVM and USDA in paper format. CVM’s 

guidance on ‘‘How to Submit a Notice of 

Intent to Slaughter for Human Food 

Purposes in Electronic Format to the 

Center for Veterinary Medicine’’ 

provides sponsors with the option for 

submitting a slaughter notice as an email attachment to CVM and USDA by 

the Internet. The electronic submission 

of slaughter notices is part of CVM’s 

ongoing initiative to provide a method 

for paperless submissions. The likely 

respondents are new animal drug 

sponsors. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the act/FDA Form # No. of. 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Responses Total Hours 

512(j)/3488 40 0.4 162 .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 is the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses are based on a review 

of the actual number of submissions 

made between January 1, 2008, and 

December 31, 2008. Sixteen total annual 

responses times .08 hours per response 

= 1.3 total hours. 

Submitting a slaughter notice 

electronically represents an alternative 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices 6035 

to submitting a notice of intent to 

slaughter on paper. The reporting 

burden for compilation and submission 

of this information on paper is included 

in OMB clearance of the information 

collection provisions of 21 CFR 511.1 

(OMB Control No. 0910–0450). The 

estimates in table 1 of this document 

reflect the burden associated with 

putting the same information on FDA 

Form 3488 and resulted from previous 

discussions with sponsors about the 

time necessary to complete this form. 

Dated: January 29, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2461 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–D–0043] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on How to Use E-Mail to 

Submit a Request for a Meeting or 

Teleconference in Electronic Format to 

The Center for Veterinary Medicine 

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 regarding 

how to use e-mail to submit a request 

for a meeting or teleconference in 

electronic format to the Center for 

Veterinary Medicine (CVM). 

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 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. 

Guidance for Industry on How to 

Submit a Request for a Meeting or 

Teleconference in Electronic Format to 

The Center for Veterinary Medicine— 

21 CFR 10.65 (OMB Control Number— 

(0910–0452)—Extension 

CVM holds meetings and/or 

teleconferences when a sponsor requests 

a presubmission conference under 21 

CFR 514.5, or requests a meeting to 

discuss general questions. Generally, 

meeting requests are submitted to CVM 

on paper. However, CVM now allows 

registered sponsors to submit 

information electronically, and to 

request meetings electronically, if they 

determine this is more efficient and 

time saving for them. CVM’s guidance 

on ‘‘How to Submit a Request for a 

Meeting or Teleconference in Electronic 

Format to CVM’’ provides sponsors with 

the option to submit a request for a 

meeting or teleconference as an e-mail 

attachment by the internet. 

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 3489 No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

10.64 40 2.4 96 .08 7.7 

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, (96 x 

hours per response (.08) = 7.7 total 

hours). 

Dated: January 28, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2459 Filed 2–4–10; 8:45 am] 

BILLING CODE 4160–01–S 


srobinson on DSKHWCL6B1PROD with NOTICES