Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 51287 

TABLE 2.—ESTIMATED RECORDKEEPING ANNUAL BURDEN1—Continued 

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Total 660 

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

The annual burden estimate for this 

information collection is 3,204 hours. 

The estimated reporting burden for this 

collection is 2,544 hours, and the 

estimated recordkeeping burden is 660 

hours. 

In the Federal Register of April 20, 

2009 (74 FR 17962), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. However, in the period of time 

since the 60-day notice was drafted, 

there was a determination of public 

health emergency involving the 2009 

H1N1 virus and multiple declarations 

supporting the issuance of EUAs. As a 

result of this increased activity and the 

likelihood of a continued increase in the 

number of EUA and pre-EUA 

submissions, on its own initiative, FDA 

is providing estimates based on the 

number of reports that the agency 

received in the past year. 

Dated: September 29, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24048 Filed 10–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0465] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Additive 

Petitions 

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 

food additive petitions regarding animal 

feed. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 7, 2009. 

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. 

Food Additive Petitions—21 CFR Part 

571 (OMB Control Number 0910– 

0546)—Extension 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe 

unless its use is permitted by a 

regulation which prescribes the 

condition(s) under which it may safely 

be used, or unless it is exempted by 

regulation for investigational use. 

Section 409(b) of the act specifies the 

information that must be submitted by 

a petition in order to establish the safety 

of a food additive and to secure the 

issuance of a regulation permitting its 

use. 

To implement the provision of section 

409 of the act, procedural regulations 

have been issued under part 571 (21 

CFR part 571). These procedural 

regulations are designed to specify more 

thoroughly the information that must be 

submitted to meet the requirement set 

down in broader terms by the law. The 

regulations add no substantive 

requirements to those indicated in the 

law, but seek to explain the 

requirements and provide a standard 

format for submission of petitions, that 

when implemented, will speed up the 

time for processing. Labeling 

requirements for food additives 

intended for animal consumption are 

also set forth in various regulations 

contained in 21 CFR parts 573, 582, and 

584. The labeling regulations are 

considered by FDA to be crossreferenced to § 571.1, which is the 

subject of this same OMB clearance for 

food additive petitions. 

FDA estimates the burden of this 

collection of information as follows: 


jlentini on DSKJ8SOYB1PROD with NOTICES
51288 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

571.1(c) moderate category 1 1 1 3,000 3,000 

571.1(c) complex category 1 1 1 10,000 10,000 

571.6 amendment of petition 2 2 4 1,300 5,200 

Total Hours 18,200 

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

FDA derived the annual reporting 

burden estimate for the different 

categories as follows: 

Section 571.1(c)—moderate category: 

For food additive petition without 

complex chemistry, manufacturing, 

efficacy, or safety issues, the estimated 

time requirement per petition is 

approximately 3,000 hours. An average 

of 1 (one) petitions of this type is 

received on an annual basis, resulting in 

a burden of 3,000 hours. 

Section 571.1(c)—complex category: 

For a food additive petition with 

complex chemistry, manufacturing, 

efficacy, and/or safety issues, the 

estimated time requirement per petition 

is approximately 10,000 hours. An 

average of 1 (one) petition of this type 

is received on an annual basis, resulting 

in a burden of 10,000 hours. 

Section 571.6: For a food additive 

petition amendment, the estimated time 

requirement per petition is 

approximately 1,300 hours. An average 

of 4 (four) petitions of this type is 

received on an annual basis, resulting in 

a burden of 5,200 hours. 

Thus, the estimated total annual 

burden for this information collection is 

18,200 hours. 

Dated: September 29, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24047 Filed 10–05–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Establishment 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2), the Director, National 

Institutes of Health (NIH), announces 

the establishment of the Interagency 

Breast Cancer and Environmental 

Research Coordinating Committee 

(Committee). 

The Committee shall coordinate all 

efforts within the Department of Health 

and Human Services to share and 

coordinate information on existing 

research activities, and make 

recommendations to the Secretary 

DHHS, the National Institutes of Health 

and other Federal agencies regarding 

how to improve existing research 

programs. 

The Committee’s primary mission is 

to facilitate the efficient and effective 

exchange of information on breast 

cancer research activities among the 

member agencies, and to coordinate 

solicitation of proposals for 

collaborative, multidisciplinary 

research, including proposals to 

evaluate environmental and genomic 

factors that may be related to the 

etiology of breast cancer. 

Duration of this committee is two 

years from the date the Charter is filed. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. E9–23974 Filed 10–5–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–M–0033, FDA– 

2009–M–0016, FDA–2009–M–0034, FDA– 

2009–M–0049, FDA–2009–M–0071, FDA– 

2009–M–0127, FDA–2009–M–0128, FDA– 

2009–M–0135, FDA–2009–M–0159] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1650, 

Silver Spring, MD 20993, 301–796– 

6570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 


jlentini on DSKJ8SOYB1PROD with NOTICES