13392 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 

Dated: March 10, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–05796 Filed 3–12–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0397] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; State Enforcement 

Notifications 

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 invites comments on 

reporting requirements contained in 

existing FDA regulations governing 

State enforcement notifications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 12, 2015. 

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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, we are publishing notice of 

the proposed collection of information 

set forth in this document. 

With respect to the following 

collection of information, we invite 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of our functions, including whether the 

information will have practical utility; 

(2) the accuracy of our 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. 

State Enforcement Notifications—21 

CFR 100.2(d) (OMB Control Number 

0910–0275)—Extension 

Section 310(b) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 337(b)) authorizes a State to 

enforce certain sections of the FD&C Act 

in their own name and within their own 

jurisdiction. However, before doing so, 

a State must provide notice to FDA 

according to 21 CFR 100.2. The 

information required in a letter of 

notification under § 100.2(d) enables us 

to identify the food against which a 

State intends to take action and to 

advise that State whether Federal 

enforcement action against the food has 

been taken or is in process. With certain 

narrow exceptions, Federal enforcement 

action precludes State action under the 

FD&C Act. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondents 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

100.2(d) ................................................................................ 1 1 1 10 10 

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

The estimated reporting burden for 

§ 100.2(d) is minimal because 

enforcement notifications are seldom 

used by States. During the last 3 years, 

we have not received any new 

enforcement notifications; therefore, we 

estimate that one or fewer notifications 

will be submitted annually. Although 

we have not received any new 

enforcement notifications in the last 3 

years, we believe these information 

collection provisions should be 

extended to provide for the potential 

future need of a State government to 

submit enforcement notifications 

informing us when it intends to take 

enforcement action under the FD&C Act 

against a particular food located in the 

State. 

Dated: March 9, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05668 Filed 3–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Ear, Nose, and Throat Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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