30940 Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices 

Jeffrey M. Zirger, 

Acting Chief, Office of Scientific Integrity, 

Office of the Associate Director for Science, 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–14172 Filed 6–29–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2027] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Survey of Current 

Manufacturing Practices for the 

Cosmetics Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a new information 

collection: A survey of the cosmetics 

industry on their current manufacturing 

practices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 31, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 31, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of August 31, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–2027 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Survey of 

Current Manufacturing Practices for the 

Cosmetics Industry.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 

9 a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices 30941 

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. 

Survey of Current Manufacturing 

Practices for the Cosmetics Industry— 

OMB Control Number 0910—New 

FDA has the responsibility to protect 

public health and, as part of this broad 

mandate, oversees the safety of the 

nation’s cosmetic products. The Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) prohibits the introduction into 

interstate commerce of any cosmetic 

that is adulterated or misbranded. 

The FD&C Act defines cosmetics as 

articles intended to be rubbed, poured, 

sprinkled, or sprayed on, introduced 

into, or otherwise applied to the human 

body for cleansing, beautifying, 

promoting attractiveness, or altering the 

appearance. Among the products 

included in this definition are skin 

moisturizers, perfumes, lipsticks, 

fingernail polishes, eye and facial 

makeup, cleansing shampoos, 

permanent waves, hair colors, 

deodorants, and tattoo inks, as well as 

any substance intended for use as a 

component of a cosmetic product. Some 

cosmetic products are also regulated as 

drugs. 

As with other commodities FDA 

regulates, the safety of cosmetic 

products can be ensured in part through 

a manufacturer’s approach to the 

management of cosmetic quality. To 

date, FDA has not identified in the 

published literature any systematic, 

detailed study of the diversity of the 

practices and standards employed 

across the cosmetic industry to ensure 

product quality and safety. This study is 

intended to fill this gap. FDA proposes 

to conduct a voluntary survey of 

cosmetics establishments to identify the 

current quality management and safety 

practices in the cosmetic industry. 

The survey instrument will collect 

data, on a voluntary basis, from 

cosmetic product manufacturers on the 

following topics: 

• Written Procedures and 

Documentation—including written 

procedures and records for 

manufacturing involving personnel, raw 

materials, processing, cleaning, 

maintenance, finished products, and 

training. 

• Buildings and Equipment— 

including facility space, pest control, 

practices ensuring the cleanliness and 

sanitation, water usage and treatment, 

and the proper functioning and 

operation of equipment. 

• Materials and Manufacturing— 

including practices for inventory 

management, labeling and storage of 

raw materials, closures, and in process 

materials; and in process standard 

operating procedures. 

• Quality Control/Product Testing— 

including the scope of the quality 

control unit, laboratory testing, dealing 

with rejected or returned products and 

complaints, and corrective actions. 

In addition, FDA will obtain the 

characteristics of surveyed 

establishments such as the types of 

cosmetics produced, published 

standards and guidelines followed, the 

number of employees, the volume of 

production, and the approximate 

revenue. The survey will be 

administered by web or by mail 

(respondent choice) and it will be 

directed to the Plant Manager of the 

cosmetics establishment. 

This is a new, one-time data 

collection. FDA does not plan to collect 

this data from the cosmetics industry on 

an ongoing basis. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Survey Invitation ......................................................... 898 1 898 0.08 (5 minutes) ...... 71.84 

Survey ........................................................................ 564 1 564 0.5 (30 minutes) ...... 282.00 

Total .................................................................... ........................ ........................ ........................ ................................. 353.84 

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

We will select a sample of 898 

establishments. After adjusting for 

ineligibility (i.e., firms that do not 

produce cosmetic products and those no 

longer in operation) and a response rate 

of 70 percent, we expect 564 completed 

surveys. 

We expect each individual survey 

invitation to take 5 minutes (0.08 hour) 

to complete. Multiplying by the 898 

establishments that will receive the 

survey invitation, we estimate the time 

burden of the survey invitation to be 

71.84 hours. We expect each individual 

survey to take 30 minutes (0.5 hour) to 

complete. Multiplying by the estimated 

564 establishments that will complete 

the survey, we estimate the time burden 

of the survey to be 282 hours. We 

estimate the total hourly reporting 

burden for this collection of information 

to be 353.84 hours. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14158 Filed 6–29–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Lists of Designated Primary Medical 

Care, Mental Health, and Dental Health 

Professional Shortage Areas 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice informs the public 

of the availability of the complete lists 

of all geographic areas, population 

groups, and facilities designated as 

primary medical care, mental health, 

and dental health professional shortage 


daltland on DSKBBV9HB2PROD with NOTICES