11368 Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 

of Dockets Management (see ADDRESSES) 

regarding this guidance document at 

any time. 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. The draft final guidance and 

received comments may be seen in the 

office above between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft final guidance 

document at http://www.cfsan.fda.gov/ 

~dms/guidance.html. 

Dated: March 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4446 Filed 3–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0073] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Control of 

Communicable Diseases; Restrictions 

on African Rodents, Prairie Dogs, and 

Certain Other Animals 

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 information collection requirements 

establishing restrictions on the import, 

capture, transport, sale, barter, 

exchange, distribution, and release of 

African rodents, prairie dogs, and 

certain other animals. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 14, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857,301–827–

4659. 

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. 

Control of Communicable Diseases; 

African Rodents and Other Animals 

That May Carry the Monkeypox 

Virus—21 CFR 1240.63 (OMB Control 

Number 0910–0519)—Extension 

Under 21 CFR 1240.63(a)(2)(ii), an 

individual must submit a written 

request to seek permission to capture, 

offer to capture, transport, offer to 

transport, sell, barter, or exchange, offer 

to sell, barter, or exchange, distribute, 

offer to distribute, and/or release into 

the environment any of the following 

animals: 

• Prairie dogs (Cynomys sp.), 

• African Tree squirrels (Heliosciurus 

sp.), 

• Rope squirrels (Funisciurus sp.), 

• African Dormice (Graphiurus sp.), 

• Gambian giant pouched rats 

(Cricetomys sp.), 

• Brush-tailed porcupines (Atherurus 

sp.), 

• Striped mice (Hybomys sp.), or 

• Any other animal so prohibited by 

order of the Commissioner of Food and 

Drugs (the Commissioner) because of 

that animal’s potential to transmit the 

monkeypox virus. 

The request cannot seek written 

permission to sell, barter, or exchange, 

or offer to sell, barter, or exchange, as 

a pet, the animals listed previously or 

any animal covered by an order by the 

Commissioner. 

The request must state the reasons 

why an exemption is needed, describe 

the animals involved, and explain why 

an exemption will not result in the 

spread of monkeypox within the United 

States. 

Our estimates are based on our 

current experience with the interim 

final rule. To estimate the number of 

respondents, we examined the number 

of requests we have received in fiscal 

year 2006. There were 122 requests, 

submitted by 65 individuals, in that 

time, and this figure represents a minor 

increase over the previous estimate of 

120 annual responses. (See 69 FR 7752 

(February 19, 2004).) As we cannot 

determine whether the latest data 

indicates a trend towards more requests 

or is an anomaly, we have elected to 

increase our estimate to 122 requests. 

We also have revised the estimated 

number of respondents to 65 (compared 

to 120 in our previous estimate) and, as 

a result, adjusted the annual frequency 

per response to 1.88 (which represents 

122 responses/65 respondents; the 

actual result is 1.8769, which we have 

rounded up to 1.88). 

Furthermore, consistent with our 

earlier Paperwork Reduction Act 

submission, we will estimate that each 

respondent will need 4 hours to 

complete its request for an exemption. 

Therefore, the total reporting burden 

under 21 CFR 1240.63(a)(2)(ii)(A) and 

(B) will be 488 hours (122 responses x 

4 hours per response = 488 hours). 

FDA estimates the burden of this 

collection of information as follows: 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 11369 

ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total No. of 

Responses 

Hours per 

Response Total Hours 

1240.63(a)(2)(ii)(A) and (B) 65 1.88 122 4 488 

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

Dated: March 6, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4450 Filed 3–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0130] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Food Labeling; Trans Fatty Acids in 

Nutrition Labeling 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Food Labeling; Trans Fatty Acids in 

Nutrition Labeling’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857,301–827–

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 12, 2006 (71 

FR 60157), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0515. The 

approval expires on January 31, 2010. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: March 6, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4454 Filed 3–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0257] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Recordkeeping Requirements for 

Human Food and Cosmetics 

Manufactured From, Processed With, 

or Otherwise Containing, Material from 

Cattle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Recordkeeping Requirements for 

Human Food and Cosmetics 

Manufactured From, Processed With, or 

Otherwise Containing, Material from 

Cattle’’ has been approved by the Office 

of Management and Budget (OMB) 

under the Paperwork Reduction Act of 

1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857,301–827–

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 11, 2006 (71 

FR 59653), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0597. The 

approval expires on January 31, 2010. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: March 6, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4455 Filed 3–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0069] 

Animal Drug User Fee Act; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

on the Animal Drug User Fee Act of 

2003 (ADUFA) to seek public comments 

relative to the program’s overall 

performance and reauthorization as 

directed by Congress. 

Date and Time: The public meeting 

will be held on April 24, 2007, 

beginning at 9 a.m. 

Location: The public meeting will be 

held at the Food and Drug 

Administration, 7519 Standish Pl., third 

floor, rm. A, Rockville, MD 20855. 

There is parking near the building. 

Photo identification is required to clear 

building security. 

Contact: Aleta Sindelar, Office of the 

Director (HFV–3), Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9004, 

FAX 240–276–9020, e-mail: 

aleta.sindelar@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Registration is not 

required to attend the meeting. Requests 

to make an oral presentation at the 

meeting must be submitted by April 17, 

2007, to the contact person. Your 

request to make a presentation should 

include the following information: 

Name, title, firm name, address, 

telephone, fax number, and e-mail 

address. We will try to accommodate all 

persons who wish to make a 

presentation. The time allotted for 


cprice-sewell on PROD1PC66 with NOTICES