20498 Federal Register / Vol. 80, No. 73 / Thursday, April 16, 2015 / Notices 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–08684 Filed 4–15–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0672] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prominent and 

Conspicuous Mark of Manufacturers 

on Single-Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 18, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0577. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Prominent and Conspicuous Mark of 

Manufacturers On Single-Use Devices 

(OMB Control Number 0910–0577)— 

Extension 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements that the label 

or labeling of a medical device must 

meet so that it is not misbranded and 

subject to regulatory action. Section 301 

of the Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250) amended section 502 of the FD&C 

Act to add section 502(u) to require 

devices (both new and reprocessed) to 

bear prominently and conspicuously the 

name of the manufacturer, a generally 

recognized abbreviation of such name, 

or a unique and generally recognized 

symbol identifying the manufacturer. 

Section 2(c) of the Medical Device 

User Fee Stabilization Act of 2005 (Pub. 

L. 109–43) amends section 502(u) of the 

FD&C Act by limiting the provision to 

reprocessed single-use devices (SUDs) 

and the manufacturers who reprocess 

them. Under the amended provision, if 

the original SUD or an attachment to it 

prominently and conspicuously bears 

the name of the manufacturer, then the 

reprocessor of the SUD is required to 

identify itself by name, abbreviation, or 

symbol in a prominent and conspicuous 

manner on the device or attachment to 

the device. If the original SUD does not 

prominently and conspicuously bear the 

name of the manufacturer, the 

manufacturer who reprocesses the SUD 

for reuse may identify itself using a 

detachable label that is intended to be 

affixed to the patient record. 

The requirements of section 502(u) of 

the FD&C Act impose a minimal burden 

on industry. This section of the FD&C 

Act only requires the manufacturer, 

packer, or distributor of a device to 

include their name and address on the 

labeling of a device. This information is 

readily available to the establishment 

and easily supplied. From its 

registration and premarket submission 

database, FDA estimates that there are 

67 establishments that distribute 

approximately 427 reprocessed SUDs. 

Each response is anticipated to take 0.1 

hours (6 minutes) resulting in a total 

burden to industry of 43 hours. 

In the Federal Register of December 

30, 2014 (79 FR 78445), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2

Type of respondent Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Establishments listing fewer than 10 SUDs ....................... 58 2 116 0.1 (6 minutes) 12 

Establishments listing 10 or more SUDs ............................ 9 34 306 0.1 (6 minutes) 31 

Total ............................................................................. ...................... ............................ ........................ ......................... 43 

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

2 Numbers have been rounded. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 73 / Thursday, April 16, 2015 / Notices 20499 

Dated: April 13, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08749 Filed 4–15–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0449] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Sun Protection 

Factor Labeling and Testing 

Requirements and Drug Facts Labeling 

for Over-the-Counter Sunscreen Drug 

Products 

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 

Sun Protection Factor (SPF) labeling 

and testing requirements for over-thecounter (OTC) sunscreen products 

containing specified ingredients and 

marketed without approved 

applications, and on compliance with 

Drug Facts labeling requirements for all 

OTC sunscreen products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 15, 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, 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. 

SPF Labeling and Testing Requirements 

for OTC Sunscreen Products Containing 

Specified Active Ingredients and 

Marketed Without Approved 

Applications, and Drug Facts Labeling 

for All OTC Sunscreen Products—21 

CFR 201.327(a)(1) and (i), 21 CFR 

201.66(c) and (d) (OMB Control Number 

0910–0717)—Extension 

In the Federal Register of June 17, 

2011 (76 FR 35620) we published a final 

rule establishing labeling and 

effectiveness testing requirements for 

certain OTC sunscreen products 

containing specified active ingredients 

without approved applications (2011 

sunscreen final rule; § 201.327 (21 CFR 

201.327)). In addition to establishing 

testing requirements, this sunscreen 

final rule lifts the delay of 

implementation of the prior 1999 

sunscreen final rule (published May 21, 

1999, at 64 FR 27666 and stayed 

December 31, 2001, 66 FR 67485) from 

complying with the 1999 labeling final 

rule (published March 17, 1999, 64 FR 

13254) in which we amended our 

regulations governing requirements for 

human drug products to establish 

standardized format and content 

requirements for the labeling of all 

marketed OTC drug products in part 201 

(21 CFR part 201). Specifically, the 1999 

labeling final rule added new § 201.66 

to part 201. Section 201.66 sets content 

and format requirements for the Drug 

Facts portion of labels on OTC drug 

products. We specifically exempted 

OTC sunscreen products from 

complying with the 1999 labeling final 

rule until we lifted the stay of the 1999 

sunscreen final rule. The 2011 

sunscreen final rule became effective 

December 17, 2012, for sunscreen 

products with annual sales of $25,000 or 

more and December 17, 2013, for 

sunscreen products with annual sales of 

less than $25,000 when we published an 

extension date notice on May 11, 2012 

(77 FR 27591). 

SPF Labeling and Testing for OTC 

Sunscreens Containing Specified Active 

Ingredients and Marketed Without 

Approved Applications 

In the Federal Register of June 17, 

2011 (76 FR 35678), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information in regard to SPF labeling 

and testing requirements for OTC 

sunscreen products containing specified 

ingredients and marketed without 

approved applications. In that notice, 

we stated that § 201.327 (a)(1) requires 

the principal display panel (PDP) 

labeling of a sunscreen covered by the 

2011 final rule to include the SPF value 

determined by conducting the SPF test 

outlined in § 201.327(i). Therefore, this 

provision results in information 

collection with a third-party disclosure 

burden for manufacturers of OTC 

sunscreens covered by the rule. We 

determined that products need only 

complete the testing and labeling 

required by the rule one time, and then 

continue to utilize the resultant labeling 

(third-party disclosure) going forward 

without additional burden. This onetime testing would need to be 

conducted within the first 3 years after 

publication of the 2011 final rule for all 

OTC sunscreens covered by that rule. 

We determined that the third-party 

disclosure burden by manufacturers of 

OTC sunscreens covered by the rule was 

based on an estimate: (1) Of the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing each 

collection of information; (2) on the 


tkelley on DSK3SPTVN1PROD with NOTICES