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
30942 Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices 

areas (HPSAs) as of May 1, 2018. The 

lists are available on HRSA’s HPSAFind 

website. 

ADDRESSES: Complete lists of HPSAs 

designated as of May 1, 2018, are 

available on the HPSAFind website at 

https://datawarehouse.hrsa.gov/tools/ 

analyzers/hpsafind.aspx. Frequently 

updated information on HPSAs is 

available at http://

datawarehouse.hrsa.gov. Information on 

shortage designations is available at 

https://bhw.hrsa.gov/shortagedesignation. 

FOR FURTHER INFORMATION CONTACT: For 

further information on the HPSA 

designations listed on the HPSAFind 

website or to request additional 

designation, withdrawal, or 

reapplication for designation, please 

contact Melissa Ryan, Acting Director, 

Division of Policy and Shortage 

Designation, Bureau of Health 

Workforce, HRSA, 11SWH03, 5600 

Fishers Lane, Rockville, Maryland 

20857, (301) 594–5168 or MRyan@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 332 of the Public Health 

Service (PHS) Act, 42 U.S.C. 254e, 

provides that the Secretary shall 

designate HPSAs based on criteria 

established by regulation. HPSAs are 

defined in section 332 to include (1) 

urban and rural geographic areas with 

shortages of health professionals, (2) 

population groups with such shortages, 

and (3) facilities with such shortages. 

Section 332 further requires that the 

Secretary annually publish lists of the 

designated geographic areas, population 

groups, and facilities. The lists of 

HPSAs are to be reviewed at least 

annually and revised as necessary. 

Final regulations (42 CFR part 5) were 

published in 1980 that include the 

criteria for designating HPSAs. Criteria 

were defined for seven health 

professional types: Primary medical 

care, dental, psychiatric, vision care, 

podiatric, pharmacy, and veterinary 

care. The criteria for correctional facility 

HPSAs were revised and published on 

March 2, 1989 (54 FR 8735). The criteria 

for psychiatric HPSAs were expanded to 

mental health HPSAs on January 22, 

1992 (57 FR 2473). Currently-funded 

PHS Act programs use only the primary 

medical care, mental health, or dental 

HPSA designations. 

HPSA designation offers access to 

potential federal assistance. Public or 

private nonprofit entities are eligible to 

apply for assignment of National Health 

Service Corps (NHSC) personnel to 

provide primary medical care, mental 

health, or dental health services in or to 

these HPSAs. NHSC health 

professionals enter into service 

agreements to serve in federally 

designated HPSAs. Entities with clinical 

training sites located in HPSAs are 

eligible to receive priority for certain 

residency training program grants 

administered by HRSA’s Bureau of 

Health Workforce (BHW). Other federal 

programs also utilize HPSA 

designations. For example, under 

authorities administered by the Centers 

for Medicare and Medicaid Services, 

certain qualified providers in 

geographic area HPSAs are eligible for 

increased levels of Medicare 

reimbursement. 

Content and Format of Lists 

The three lists of designated HPSAs 

are available on the HPSAFind website 

and include a snapshot of all geographic 

areas, population groups, and facilities 

that were designated HPSAs as of May 

1, 2018. This notice incorporates the 

most recent annual reviews of 

designated HPSAs and supersedes the 

HPSA lists published in the Federal 

Register on June 26, 2017 (Federal 

Register/Vol. 82, No. 121/Monday, June 

26, 2017/Notices 28863). 

In addition, all Indian Tribes that 

meet the definition of such Tribes in the 

Indian Health Care Improvement Act of 

1976, 25 U.S.C. 1603(d), are 

automatically designated as population 

groups with primary medical care and 

dental health professional shortages. 

Further, the Health Care Safety Net 

Amendments of 2002 provides 

eligibility for automatic facility HPSA 

designations for all federally qualified 

health centers (FQHCs) and rural health 

clinics that offer services regardless of 

ability to pay. Specifically, these entities 

include FQHCs funded under section 

330 of the PHS Act, FQHC Look-Alikes, 

and Tribal and urban Indian clinics 

operating under the Indian SelfDetermination and Education Act of 

1975 (25 U.S.C. 450) or the Indian 

Health Care Improvement Act. Many, 

but not all, of these entities are included 

on this listing. Absence from this list 

does not exclude them from HPSA 

designation; facilities eligible for 

automatic designation are included in 

the database when they are identified. 

Each list of designated HPSAs is 

arranged by state. Within each state, the 

list is presented by county. If only a 

portion (or portions) of a county is (are) 

designated, a county is part of a larger 

designated service area, or a population 

group residing in a county or a facility 

located in the county has been 

designated, the name of the service area, 

population group, or facility involved is 

listed under the county name. A county 

that has a whole county geographic 

HPSA is indicated by the phrase ‘‘Entire 

county HPSA’’ following the county 

name. 

Development of the Designation and 

Withdrawal Lists 

Requests for designation or 

withdrawal of a particular geographic 

area, population group, or a facility as 

a HPSA are received continuously by 

BHW. Under a Cooperative Agreement 

between HRSA and the 54 state and 

territorial Primary Care Offices (PCOs), 

PCOs conduct needs assessments and 

submit the majority of the applications 

to HRSA to designate areas as HPSAs. 

BHW refers requests that come from 

other sources to PCOs for review. In 

addition, interested parties, including 

Governors, State Primary Care 

Associations, and state professional 

associations, are notified of requests so 

that they may submit their comments 

and recommendations. 

BHW reviews each recommendation 

for possible addition, continuation, 

revision, or withdrawal. Following 

review, BHW notifies the appropriate 

agency, individuals, and interested 

organizations of each designation of a 

HPSA, rejection of recommendation for 

HPSA designation, revision of a HPSA 

designation, and/or advance notice of 

pending withdrawals from the HPSA 

list. Designations (or revisions of 

designations) are effective as of the date 

on the notification from BHW and are 

updated daily on the HPSAFind 

website. The effective date of a 

withdrawal will be the next publication 

of a notice regarding the list in the 

Federal Register. 

Dated: June 26, 2018. 

George Sigounas, 

Administrator. 

[FR Doc. 2018–14115 Filed 6–29–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990—new] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 


daltland on DSKBBV9HB2PROD with NOTICES