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
20500 Federal Register / Vol. 80, No. 73 / Thursday, April 16, 2015 / Notices 

conduct of SPF testing based on the 

estimated number of existing 

formulations; (3) of the time to relabel 

currently marketed OTC sunscreens 

containing specified ingredients and 

marketed without approved 

applications; and (4) on testing and 

labeling of new products introduced 

each year. The estimate for this burden 

in the 2011 60-day PRA notice was a 

total of 30,066 hours in years one and 

two and a total burden of 966 in each 

subsequent year. 

All currently marketed OTC 

sunscreen drug products are required at 

this time to be in compliance with the 

SPF labeling requirements specified by 

the 2011 final rule. However, our 

original estimate included the burden of 

new products introduced each year. We 

estimated that as many as 60 new OTC 

sunscreen products stock keeping units 

(SKUs) may be introduced each year 

which will have to be tested and labeled 

with the SPF value determined in the 

test. We estimated that the 60 new 

sunscreen SKUs represent 39 new 

formulations. The burden for testing and 

labeling these formulations was 

estimated at 30 hours per year. 

We have received no further 

comments on our estimate of burden for 

the collection of this information other 

than two comments (FDA–2011–N– 

0449–0002 and FDA–2011–N–0449– 

0003). These comments were already 

addressed in FDA’s notice of 

‘‘Information Collection Activities; 

Submission for Office of Management 

and Budget Review; Comment Request; 

Sun Protection Factor Labeling and 

Testing Requirements and Drug Facts 

Labeling for Over-the Counter 

Sunscreen Drug Products’’ published on 

May 9, 2012 (77 FR 27230). 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Conduct SPF testing in accordance with § 201.327(i) for 

new sunscreens.

20 1.95 39 24 .................... 936 

Create PDP labeling in accordance with § 201.327(a)(1) 

for new sunscreen SKUs.

20 3 60 0.5 (30 min.) ... 30 

Total ............................................................................. ...................... ............................ ........................ ......................... 966 

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

Drug Facts Labeling for OTC Sunscreens 

Because the 2011 final rule also lifts 

the delay of implementation of the Drug 

Facts regulations (§ 201.66) for OTC 

sunscreens, the rule also modifies the 

information collection associated with 

§ 201.66 (currently approved under 

OMB control number 0910–0340) and 

adds an additional third-party 

disclosure burden resulting from 

requiring OTC sunscreen products to 

comply with Drug Facts regulations. In 

the Federal Register of March 17, 1999 

(64 FR 13254), 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, codified 

in § 201.66 (the 1999 Drug Facts labeling 

final rule). Section 201.66 sets 

requirements for the Drug Facts portion 

of labels on OTC drug products, 

requiring such labeling to include 

uniform headings and subheadings, 

presented in a standardized order, with 

minimum standards for type size and 

other graphical features. Therefore, 

currently marketed OTC sunscreen 

products will incur a one-time burden 

to comply with the requirements in 

§ 201.66(c) and (d). The burden was 

estimated in the 60-day PRA notice 

published in the Federal Register of 

June 17, 2011 (76 FR 35678) as 43,200 

hours for existing sunscreen SKUs and 

720 hours for new sunscreen SKUs. 

The compliance dates for the 2011 

final rule lifting the delay of the 

§ 201.66 labeling implementation data 

for OTC sunscreen products were 

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, respectively, when 

we published an extension date notice 

on May 11, 2012 (77 FR 27591). All 

currently marketed sunscreen products 

are, therefore, already required to be in 

compliance with the Drug Facts labeling 

requirements in § 201.66 and will incur 

no further burden in the 1999 labeling 

final rule. However, new OTC sunscreen 

drug products will be subject to a onetime burden to comply with Drug Facts 

labeling requirements in § 201.66. In the 

2011 60-day PRA, we estimated that as 

many as 60 new product SKUs marketed 

each year will have to comply with Drug 

Facts regulations. We estimated that 

these 60 SKUs would be marketed by 30 

manufacturers. We estimated that 

approximately 12 hours would be spent 

on each label, based on the most recent 

estimate used for other OTC drug 

products to comply with the Drug Facts 

labeling final rule, including public 

comments received on this estimate in 

2010 that addressed sunscreens. This is 

equal to 720 hours annually (60 SKUs 

× 12 hours/SKU). We stated that we do 

not expect any OTC sunscreens to apply 

for exemptions or deferrals of the Drug 

Facts regulations in § 201.66(e). 

However, we took this into 

consideration in 2013 and estimated the 

burden for an exemption or deferral by 

considering the number of exemptions 

or deferrals we have received since 

publication of the 1999 final rule (one 

response) and estimating that a request 

for deferral or exemption would require 

24 hours to complete. Multiplying the 

annual frequency of response (0.125) by 

the number of hours per response (24) 

gives a total response time for 

requesting an exemption or deferral 

equal to 3 hours. 

We estimate the burden of this 

collection of information as follows: 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 73 / Thursday, April 16, 2015 / Notices 20501 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Format labeling in accordance with § 201.66(c) and (d) 

for new sunscreen SKUs ............................................. 20 3 60 12 720 

Request for Drug Facts exemption or deferral 

§ 201.66(e) .................................................................... 1 0.125 0.125 24 3 

Total .......................................................................... ...................... ............................ ........................ ............................ 723 

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

Dated: April 13, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08750 Filed 4–15–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects (section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995), the 

Health Resources and Services 

Administration (HRSA) announces 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). Prior to submitting the 

ICR to OMB, HRSA seeks comments 

from the public regarding the burden 

estimate, below, or any other aspect of 

the ICR. 

DATES: Comments on this Information 

Collection Request must be received no 

later than June 15, 2015. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 10C–03, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call the HRSA Information Collection 

Clearance Officer at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Maternal, Infant, and Childhood Home 

Visiting (Home Visiting) Program fiscal 

year (FY) 2015, FY2016, FY2017 NonCompeting Continuation Progress 

Report for Formula Grant. 

OMB No. 0915–0355—Extension. 

Abstract: The Maternal, Infant, and 

Early Childhood Home Visiting (Home 

Visiting) Program, administered by the 

Health Resources and Services 

Administration (HRSA), in close 

partnership with the Administration for 

Children and Families (ACF), supports 

voluntary, evidence-based home visiting 

services during pregnancy and to 

parents with young children up to 

kindergarten entry. The purpose of this 

formula grant program is to support the 

delivery of coordinated and 

comprehensive voluntary early 

childhood home visiting program 

services and effective implementation of 

high-quality evidence-based practices. 

Fifty states, the District of Columbia, 5 

territories, and eligible nonprofit 

organizations are eligible for formula 

grants and submit non-competing 

continuation progress reports annually. 

There are 56 jurisdictions/entities 

eligible for formula awards, and 56 

formula awards are issued annually. 

Need and Proposed Use of the 

Information: This information collection 

is needed for grantees to report progress 

under the Home Visiting Program 

annually. On March 23, 2010, the 

President signed into law the Patient 

Protection and Affordable Care Act 

(ACA). Section 2951 of the ACA 

amended title V of the Social Security 

Act by adding a new section, 511, which 

authorized the Home Visiting Program 

(http://frwebgate.access.gpo.gov/cgi-bin/

getdoc.cgi?dbname=111_cong_

bills&docid=f:h3590enr.txt.pdf, pages 

216–225). Congress extended funding 

for the Home Visiting Program by the 

Protecting Access to Medicare Act of 

2014 (Pub. L. 113–93). A portion of 

funding provided under this program is 

awarded to participating states, 

jurisdictions, and entities by formula. 

The information collected will be 

used to review grantee progress on 

proposed project plans to assess 

whether the project is performing 

adequately to achieve the goals and 

objectives that were previously 

approved. This report will also provide 

implementation plans for the upcoming 

year, to permit assessment of whether 

the plan is consistent with the grant as 

approved, and is expected to, will result 

in, implementation of a high-quality 

project that will complement the Home 

Visiting Program as a whole. Progress 

Reports are submitted through the 

Electronic Handbooks. Failure to collect 

this information would impair federal 

monitoring and oversight of the use of 

grant funds in keeping with legislative 

and policy requirements. Grantees are 

required to provide a performance 

narrative with the following sections: 

Project identifier information; 

accomplishments and barriers; Home 

Visiting Program goals and objectives; 

update on the Home Visiting Program 

promising approach; implementation of 

the Home Visiting Program in targeted 

at-risk communities; progress toward 

meeting legislatively-mandated 

reporting on benchmark areas; home 

visiting quality improvement efforts; 

and updates on the administration of 

the Home Visiting Program. 

Likely Respondents: Grantees with 

Home Visiting Formula Awards 

Awarded in Federal FY 2013–FY 2017. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 


tkelley on DSK3SPTVN1PROD with NOTICES