Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39795 

for labeling are included in the estimate 

for § 71.1. Also, because labeling 

requirements under parts 172, 173, 179, 

and 180 for particular food additives 

involve information required as part of 

the FAP safety review process under 

§ 171.1, the burden hours for labeling 

are included in the estimate for § 171.1. 

Dated: August 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17703 Filed 8–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0623] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary 

Cosmetic Registration Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 

(PRA). 

DATES: Fax written comments on the 

collection of information by September 

21, 2017. 

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 0910–0027. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A63, 11601 Landsdown 

St., North Bethesda, MD 20852, 301– 

796–7726, 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. 

Voluntary Cosmetic Registration 

Program—21 CFR Parts 710 and 720 

OMB Control Number 0910–0027— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) provides us with the 

authority to regulate cosmetic products 

in the United States. Cosmetic products 

that are adulterated under section 601 of 

the FD&C Act (21 U.S.C. 361) or 

misbranded under section 602 of the 

FD&C Act (21 U.S.C. 362) may not be 

distributed in interstate commerce. We 

have developed the Voluntary Cosmetic 

Registration Program (VCRP) to assist us 

in carrying out our responsibility to 

regulate cosmetics. 

FDA is revising forms for the VCRP 

(Forms FDA 2511, 2512, 2512a, and 

2514) currently approved under OMB 

control number 0910–0027, ‘‘Voluntary 

Cosmetic Registration Program,’’ for the 

following reasons: (1) Modernizing the 

forms; (2) Making it easier for filers who 

complete the forms; and (3) reducing the 

time it will take FDA to review each 

submission. In addition, Form FDA 

2514 will be eliminated as it duplicates 

information that is currently located on 

Form FDA 2512. FDA requests PRA 

approval for the proposed changes to 

these forms, and for the elimination of 

Form FDA 2514. 

Participation in the VCRP is voluntary 

under provisions found in sections parts 

710 and 720 (21 CFR parts 710 and 720). 

Participants have the option of 

submitting information via paper forms 

or via the online interface. The term 

‘‘form’’ refers to both the paper form and 

the online system. 

Currently, in part 710, we request that 

establishments that manufacture or 

package cosmetic products voluntarily 

register with us using Form FDA 2511 

entitled ‘‘Registration of Cosmetic 

Product Establishment.’’ The online 

version of Form FDA 2511 is available 

on our VCRP Web site at https://

www.fda.gov/Cosmetics/Registration

Program/default.htm. We strongly 

encourage online registration with Form 

FDA 2511 because it is faster and more 

efficient for the filer and the Agency. A 

registering facility will receive 

confirmation of online registration, 

including a registration number by 

email. The online system also allows for 

amendments to past submissions. 

Because registration of cosmetic 

product establishments is not 

mandatory, voluntary registration 

provides FDA with the best information 

available about the locations, business 

trade names, and types of activity 

(manufacturing or packaging) of 

cosmetic product establishments. We 

place the registration information in a 

computer database and use the 

information to generate lists for 

distributing regulatory information and 

for inviting firms to participate in 

workshops on topics in which they may 

be interested. Registration is permanent, 

although we request that respondents 

submit an amended Form FDA 2511 if 

any of the originally submitted 

information changes. 

FDA’s proposed changes to the forms 

through the use of an electronic 

submission system have been designed 

to make it easier for participants to 

provide information to FDA about their 

products. The system also assists 

participants, through interactive 

question and response scenarios, to 

identify submissions that will be 

ineligible to be accepted in VCRP 

because they do not meet parts 710 and 

720 requirements. The electronic 

submission system is expected to reduce 

burden currently associated with the 

manual identification process for filers 

and FDA. The rejection rate for 

ineligible submissions when using the 

current forms is high: 51 percent for 

new accounts, 43 percent for Form FDA 

2511 registrations, and 7 percent for 

Form FDA 2512 filings (2010–2016). 

The revised forms include the 

addition of links between Forms FDA 

2511 and 2512, clarification of what 

information should be entered onto the 

forms, additional self-identifying fields, 

removal of certain duplicative fields, 

and the deletion of Form FDA 2514. 

These changes are needed because both 

VCRP voluntary filer participation and 

FDA resources required to administer 

VCRP have increased significantly since 

2014 (i.e., increases in new accounts 

(156 percent), Form FDA 2511 

registrations (405 percent), Form FDA 

2512 filings (67 percent), and FDA 

review hours (59 percent) in 2016.) 

FDA’s current process confirms that 

each submission meets the requirements 

established in parts 710 and 720 by 

using a manual process for both filers 

and FDA reviewers that may result in a 

long waiting period where filers must 

wait and respond to questions generated 

by FDA, which may result in a high 

rejection rate. FDA projects a significant 

reduction in rejection rates when using 

the revised forms. Examples of possible 

burden savings for participants and FDA 

include: 

(1) Form FDA 2511 asks filers if they 

are a manufacturer or packer; however, 

in the past, distributors and retailers 

have checked these boxes in error when 

neither applies to them because there 

are no distributor or retailer checkboxes 

on Form FDA 2511. Retailers have also 

filed Form FDA 2512 in error even 

though only manufacturers, packers, 


sradovich on DSK3GMQ082PROD with NOTICES
39796 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 

and distributors are permitted to do so. 

To correct these issues, FDA revised 

Form FDA 2511 by updating the field 

that allows filers to indicate the ‘‘TYPE 

OF ESTABLISHMENT: 

MANUFACTURER/PACKER/OTHER 

(Distributor or Retailer)’’ and updating 

the field on Form FDA 2512 allowing 

the filer to indicate ‘‘WHO IS FILING 

THIS STATEMENT: MANUFACTURER/ 

PACKER/DISTRIBUTOR/OTHER 

(Retailer).’’ 

(2) FDA revised Form FDA 2511 and 

added questions asking, ‘‘Are you the 

owner or operator of this facility?’’ and 

‘‘Is the address on this form the location 

of a cosmetic manufacturing and/or 

packing facility?’’ 

(3) FDA also revised Form FDA 2512 

and added questions asking, ‘‘Is this 

product currently commercially 

distributed (annual sales exceed $1,000) 

in the United States?’’, ‘‘PRODUCT 

WEBSITE’’, and ‘‘Attach images of the 

front and back product labels to this 

form’’ to ensure that only cosmetics in 

commercial distribution in the United 

States are filed in the VCRP. 

(4) FDA linked Forms FDA 2511 and 

2512 to reduce burden to filers who 

create multiple copies of Form FDA 

2512 that share the same establishment 

addresses. 

(5) FDA clarified the information that 

should be included on the forms by 

attaching simplified instructions and a 

link to VCRP online on Forms FDA 

2511, 2512, and 2512a and adding titles 

and locations of various fields 

throughout Forms FDA 2511, 2512, and 

2512a. We also added self-identifying 

information such as phone number, 

email, and alternative authorized 

individual fields to Forms FDA 2511 

and 2512 to facilitate communication 

with the filers. 

(6) We also removed fields that have 

no modern use or request redundant 

information in multiple locations. 

(7) We removed Form FDA 2514 in its 

entirety due to redundancy. (As noted, 

filers may notify FDA that they are 

discontinuing a cosmetic product 

formulation on Form FDA 2512). 

FDA’s online filing system is available 

on FDA’s VCRP Web site at https://

www.fda.gov/Cosmetics/Registration

Program/default.htm. The online filing 

system contains the online versions of 

Forms FDA 2511, 2512, and 2512a. 

We place cosmetic product filing 

information in a computer database and 

use the information when FDA receives 

inquiries about cosmetics marketed in 

the United States. Because filing of 

cosmetic product formulations is not 

mandatory, voluntary filings with FDA 

provide us with the best information 

available about cosmetic products, 

ingredients, frequency of use, 

businesses engaged in the manufacture 

and distribution of cosmetics, and 

approximate rates of product 

discontinuance and formula 

modifications. The information assists 

our scientists in evaluating reports of 

adverse events submitted via MedWatch 

and Field Operators (FACTS). We also 

use the information in identifying future 

research projects, to evaluate the levels 

and safety of certain ingredients in 

cosmetics. 

Links to explanations of the revisions 

to Forms FDA 2511, 2512, and 2512a 

and instructions are available at https:// 

www.fda.gov/Cosmetics/Registration

Program/default.htm and entitled 

‘‘Voluntary Cosmetic Registration 

Program.’’ 

In the Federal Register of May 31, 

2017 (82 FR 24977), we published a 60- 

day notice requesting public comment 

on the proposed extension of this 

collection of information. Two 

comments were received. One comment 

appeared to be a submission under 21 

CFR 10.35 and 10.40(b)(3) and therefore 

is not addressed here. The second 

comment offered suggestions that FDA 

might consider regarding the content 

and format of reporting elements, but 

made no suggestion for FDA to revise its 

burden estimate. Accordingly, while the 

Agency is currently reviewing these 

suggestions to determine whether our 

current IT system may be upgraded to 

the benefit of respondents, we retain the 

burden estimate from our 60-day notice. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section or part Form No. Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Part 710 (registrations) .................................. FDA 2511 2 .... 934 1 934 0.20 (12 minutes) .... 187 

720.1 through 720.4 (new submissions) ....... FDA 2512 3 .... 7,108 1 7,108 0.33 (20 minutes) .... 2,346 

720.6 (amendments) ...................................... FDA 2512 ...... 4,049 1 4,049 0.17 (10 minutes) .... 688 

720.6 (notices of discontinuance) .................. FDA 2512 ...... 95 1 95 0.10 (6 minutes) ...... 10 

720.8 (requests for confidentiality) ................ ........................ 1 1 1 2 .............................. 2 

Total ........................................................ ........................ .................... ...................... .................... ................................. 3,233 

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

2The term ‘‘Form FDA 2511’’ refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP, 

which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. 3The term ‘‘Form FDA 2512’’ refers to the paper Forms FDA 2512, and 2512a and online Form FDA 2512 in the online system known as the 

VCRP, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. 

We base our estimate of the total 

annual responses on paper and online 

submissions received during calendar 

year 2016. We base our estimate of the 

hours per response upon information 

from cosmetic industry personnel and 

FDA experience entering data submitted 

on paper Forms FDA 2511, 2512, and 

2512a into the online system. 

We estimate that, annually, 934 

establishments that manufacture or 

package cosmetic products will each 

submit 1 registration on Form FDA 

2511, for a total of 934 annual 

responses. Each submission is estimated 

to take 0.20 hour per response for a total 

of 186.8 hours, rounded to 187. The 

number of Form FDA 2511 submissions 

has increased 405 percent compared to 

2014 and we have no indication that 

this submission rate will stop 

increasing. We estimate that, annually, 

firms that manufacture, pack, or 

distribute cosmetics will file 7,108 

ingredient statements for new or 

amended submissions on Forms FDA 

2512 and FDA 2512a. Each submission 

is estimated to take 0.33 hour per 

response for a total of 2345.64 hours, 

rounded to 2,346. We estimate the 

number of Form FDA 2512 submissions 

to increase 67 percent compared to 2014 

and we have no indication that this 

submission rate will stop increasing. We 

estimate that, annually, firms that 

manufacture, pack, or distribute 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39797 

cosmetics will file 4,049 amendments to 

product formulations on Forms FDA 

2512 and FDA 2512a. Each submission 

is estimated to take 0.17 hour per 

response for a total of 688.33 hours, 

rounded to 688. We estimate that, 

annually, firms that manufacture, pack, 

or distribute cosmetics will file 95 

notices of discontinuance on Form FDA 

2512. Each submission is estimated to 

take 0.10 hour per response for a total 

of 9.5 hours, rounded to 10. We estimate 

that, annually, one firm will file one 

request for confidentiality. Each such 

request is estimated to take 2 hours to 

prepare for a total of 2 hours. Thus, the 

total estimated hour burden for this 

information collection is 3,233 hours. 

Dated: August 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17701 Filed 8–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[CMS–3340–N] 

Secretarial Review and Publication of 

the National Quality Forum Report of 

2016 Activities to Congress and the 

Secretary of the Department of Health 

and Human Services 

AGENCY: Office of the Secretary of 

Health and Human Services, HHS. 

ACTION: Notice. 

SUMMARY: This notice acknowledges that 

in accordance with section 1890(b)(5)(B) 

of the Social Security Act (the Act) the 

Secretary of the Department of Health 

and Human Services (the Secretary) has 

received and reviewed the National 

Quality Forum (NQF) Report of 2016 

Activities to Congress and the Secretary 

of the Department of Health and Human 

Services submitted by the consensusbased entity with whom the Secretary 

has a contract under section 1890(a) of 

the Act. The purpose of this Federal 

Register notice is to publish the report, 

together with the Secretary’s comments 

on such report. 

FOR FURTHER INFORMATION CONTACT: 

Sophia Chan, (410) 786–5050. 

I. Background 

The Secretary of the Department of 

Health and Human Services (the 

Secretary) has long recognized that a 

high functioning health care system that 

provides higher quality care requires 

accurate, valid, and reliable 

measurement of quality and efficiency. 

Section 1890(a) of the Social Security 

Act (the Act), as added by section 

183(a)(1) of the Medicare Improvements 

for Patients and Providers Act of 2008 

(MIPPA) (Pub. L. 110–275), requires the 

Secretary to identify and have in effect 

a contract with a consensus-based entity 

(CBE) to perform multiple duties 

described in subsection (b) that are 

designed to help improve performance 

measurement. The duties described in 

subsection (b) originally included a 

priority setting process, measure 

endorsement, measure maintenance, 

electronic health record promotion, and 

the preparation of an annual Report to 

Congress and the Secretary. Section 

3003(b) of the Patient Protection and 

Affordable Care Act (Pub. L. 111–148) as 

amended by the Health Care and 

Education Reconciliation Act (Pub. L. 

111–152) (collectively, the Affordable 

Care Act) expanded the duties of the 

CBE to require the CBE to review and, 

as appropriate, endorse the episode 

grouper developed by the Secretary 

under the Physician Feedback Program. 

Section 3014(a)(1) of the Affordable 

Care Act further expanded the duties to 

require the CBE to convene multistakeholder groups to provide input on 

the selection of quality and efficiency 

measures and national priorities for 

improvement in population health and 

in the delivery of health care services 

for consideration under the national 

strategy, and to transmit such input to 

the Secretary. Section 3014(a)(2) of the 

Affordable Care Act expanded the 

requirements for the annual report that 

must be submitted under section 

1890(b)(5)(A) of the Act. 

To meet the requirements of section 

1890(a) of the Act, in January of 2009, 

the Department of Health and Human 

Services (HHS) awarded a competitive 

contract to the National Quality Forum 

(NQF). A second, multi-year contract 

was awarded to NQF after an open 

competition in 2012. This contract 

includes the following duties: 

Priority Setting Process: Formulation 

of a National Strategy and Priorities for 

Health Care Performance Measurement. 

The CBE is required to synthesize 

evidence and convene key stakeholders 

to make recommendations on an 

integrated national strategy and 

priorities for health care performance 

measurement in all applicable settings. 

In doing so, the CBE is to give priority 

to measures that: (1) Address the health 

care provided to patients with 

prevalent, high-cost chronic diseases; 

(2) have the greatest potential for 

improving quality, efficiency and 

patient-centeredness of health care; and 

(3) may be implemented rapidly due to 

existing evidence, standards of care, or 

other reasons. Additionally, the CBE 

must take into account measures that: 

(1) May assist consumers and patients in 

making informed health care decisions; 

(2) address health disparities across 

groups and areas; and (3) address the 

continuum of care a patient receives, 

including across multiple providers, 

practitioners and settings. 

Endorsement of Measures. The CBE is 

required to provide for the endorsement 

of standardized health care performance 

measures. This process must consider 

whether measures are evidence-based, 

reliable, valid, verifiable, relevant to 

enhanced health outcomes, actionable at 

the caregiver level, feasible to collect 

and report, responsive to variations in 

patient characteristics such as health 

status, language capabilities, race or 

ethnicity, and income level and 

consistent across types of health care 

providers, including hospitals and 

physicians. 

Maintenance of CBE Endorsed 

Measures. The CBE is required to 

establish and implement a process to 

ensure that endorsed measures are 

updated (or retired if obsolete) as new 

evidence is developed. 

Review and Endorsement of an 

Episode Grouper Under the Physician 

Feedback Program. ‘‘Episode-based’’ 

performance measurement is an 

approach to better understanding the 

utilization and costs associated with a 

certain condition by grouping together 

all the care related to that condition. 

‘‘Episode groupers’’ are software tools 

that combine data to assess such 

condition-specific utilization and costs 

over a defined period of time. The CBE 

is required to provide for the review, 

and as appropriate, endorsement of an 

episode grouper as developed by the 

Secretary on an expedited basis. 

Convening Multi-Stakeholder Groups. 

The CBE must convene multistakeholder groups to provide input on: 

(1) The selection of certain categories of 

quality and efficiency measures, from 

among such measures that have been 

endorsed by the entity; and such 

measures that have not been considered 

for endorsement by such entity but are 

used or proposed to be used by the 

Secretary for the collection or reporting 

of quality and efficiency measures; and 

(2) national priorities for improvement 

in population health and in the delivery 

of health care services for consideration 

under the national strategy. The CBE 

provides input on measures for use in 

certain specific Medicare programs, for 

use in programs that report performance 

information to the public, and for use in 

health care programs that are not 

included under the Act. The multistakeholder groups provide input on 

quality and efficiency measures for use 

in certain federal programs including 


sradovich on DSK3GMQ082PROD with NOTICES