Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7277 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

801.150(e) 90 20 1,800 4 7,200 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours Total Operating & Maintenance Costs 

801.150(a)(2) 90 20 1,800 0.5 900 $55,800 

1There are no capital costs associated with this collection of information. 

FDA’s estimate of the reporting 

burden is based on actual data obtained 

from industry over the past several years 

where there are approximately 90 firms 

subject to this requirement. It is 

estimated that each of these firms on the 

average prepares 20 written agreements 

each year. This estimate varies greatly, 

from 1 to 100, because some firms 

provide sterilization services on a part 

time basis for only one customer while 

others are large facilities with many 

customers. The average time required to 

prepare each written agreement is 

estimated to be four hours. This 

estimate varies depending on whether 

the agreement is the initial agreement or 

an annual renewal, on the format each 

firm elects to use, and on the length of 

time required to reach agreement. The 

estimate applies only to those portions 

of the written agreement that pertain to 

the requirements imposed by this 

regulation. The written agreement 

generally also includes contractual 

agreements that are a customary and 

usual business practice. On the average, 

the total annual recordkeeping burden is 

7,200 hours (90 firms x 20 agreements 

x 4 hours). 

The recordkeeping requirements of 

§ 801.150(a)(2) consist of making copies 

and maintaining the actual reporting 

requests which were required under the 

reporting section of this collection. To 

fulfill this requirement, FDA estimates it 

will take about 30 minutes to copy each 

package, for a total of 900 recordkeeping 

hours and includes $55,800 operating 

and maintenance costs. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3027 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0055] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on How to Submit a Protocol 

Without Data 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 activity 

‘‘Guidance for Industry on How to 

Submit a Protocol Without Data in 

Electronic Format to the Center for 

Veterinary Medicine.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 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, 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. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

7278 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

Guidance for Industry on ‘‘How to 

Submit a Protocol Without Data in 

Electronic Format to the Center for 

Veterinary Medicine’’—21 CFR 58.120 

and 514.117(b) (OMB Control Number 

0910–0524—Extension) 

Protocols for nonclinical laboratory 

studies (safety studies), are required 

under 21 CFR 58.120 for approval of 

new animal drugs. Protocols for 

adequate and well-controlled 

effectiveness studies are required under 

21 CFR 514.117(b). Upon request by the 

animal drug sponsors, the Center for 

Veterinary Medicine (CVM) reviews 

protocols for safety and effectiveness 

studies. CVM and the sponsor consider 

this to be an essential part of the basis 

for making the decision to approve or 

not approve an animal drug application 

or supplemental animal drug 

application. The establishment of a 

process for acceptance of the electronic 

submission of protocols for studies 

conducted by sponsors in support of 

new animal drug applications is part of 

CVM’s ongoing initiative to provide a 

method for paperless submissions. 

Sponsors may submit protocols to CVM 

in paper format. CVM’s guidance on 

how to submit a study protocol permits 

sponsors to submit a protocol without 

data as an e-mail attachment via the 

Internet. Further, this guidance also 

electronically implements provisions of 

the Government Paperwork Elimination 

Act (GPEA). The GPEA required Federal 

agencies, by October 21, 2003, to 

provide the following: (1) The option of 

electronic maintenance, submission, or 

disclosure of information, if practicable, 

as a substitution for paper and (2) the 

use and acceptance of electronic 

signatures, where applicable. FDA Form 

3536 is used to facilitate the use of 

electronic submission of protocols. This 

collection of information is for the 

benefit of animal drug sponsors, giving 

them the flexibility to submit data for 

review via the Internet. 

The likely respondents are sponsors 

of new animal drug applications. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/FDA Form 3536 No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

514.117(b) and 58.120 40 1.8 72 .20 14.4 

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 July 1, 2005, 

and June 30, 2006, (72 x .20 hours per 

response = 14.4 total hours). 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3026 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0062] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Exception From 

General Requirements for Informed 

Consent 

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 

a new exception from the general 

requirements for informed consent to 

permit the use of investigational in vitro 

diagnostic devices to identify chemical, 

biological, radiological, or nuclear 

agents without informed consent in 

certain circumstances. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES