Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices 39761 

Desk Officer for the Administration for 

Children and Families. 

Emily B. Jabbour, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–17121 Filed 8–9–18; 8:45 am] 

BILLING CODE 4184–74–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Proposed Projects 

Title: Supplemental Nutrition 

Assistance Program (SNAP) Matching 

Program Performance Outcomes. 

OMB No. 0970–0464. 

Description: State agencies 

administering the Supplemental 

Nutrition Assistance Program (SNAP) 

are mandated to participate in a 

computer matching program with the 

federal Office of Child Support 

Enforcement (OCSE). The matching 

program compares SNAP applicant and 

recipient information with employment 

and wage information maintained in the 

National Directory of New Hires 

(NDNH). The outcomes of the compared 

information help state SNAP agencies 

with administering the program and 

verifying and determining an 

individual’s benefit eligibility. To 

receive NDNH information, state 

agencies enter into a computer matching 

agreement and adhere to its terms and 

conditions, including providing OCSE 

with annual performance outcomes 

attributable to the use of NDNH 

information. 

The Office of Management and Budget 

(OMB) requires OCSE to periodically 

report performance measurements 

demonstrating how the use of 

information in the NDNH supports 

OCSE’s strategic mission, goals, and 

objectives. OCSE will provide the 

annual SNAP performance outcomes to 

OMB. 

The information collection activities 

for the SNAP performance outcomes 

reports are authorized by: (1) Subsection 

453(j)(10) of the Social Security Act (42 

U.S.C. 653(j)(10)), which allows the 

Secretary of the U.S. Department of 

Health and Human Services to disclose 

information maintained in the NDNH to 

state agencies administering SNAP 

under the Nutrition Act of 2008, as 

amended by the Agriculture Act of 

2014; (2) the Privacy Act of 1974, as 

amended by the Computer Matching 

and Privacy Protection Act of 1988 (5 

U.S.C. 552a), which sets forth the terms 

and conditions of a computer matching 

program; and, (3) the Government 

Performance and Results Modernization 

Act of 2010 (Pub. L. 111–352), which 

requires agencies to report program 

performance outcomes to the Office of 

Management and Budget and for the 

reports to be available to the public. 

Respondents: State SNAP Agencies. 

ANNUAL BURDEN ESTIMATES

Information collection title Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

SNAP Matching Program Performance Outcomes ......................................... 53 1 1.92 101.76 

Estimated Total Annual Burden 

Hours: 101.76. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to The Administration for 

Children and Families, Office of 

Information Services, 330 C Street SW, 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–17152 Filed 8–9–18; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2582] 

Human Dermal (Skin) Safety Testing 

for Topical Drug Products: Regulatory 

Utility and Evaluation; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the following 1-day public 

workshop entitled ‘‘Human Dermal 

(Skin) Safety Testing for Topical Drug 

Products: Regulatory Utility and 

Evaluation.’’ The purpose of the public 

workshop is to provide a forum to 

discuss the current state and future 

directions of the collection of human 

data on the potential skin toxicity with 

the use of medications applied 

topically. The workshop will review 

current approaches to the collection of 

human data during the clinical 

development of topical drug products. 

The workshop will also address the 

impact of human skin toxicity studies 

on drug labeling and consider 

alternative approaches to providing 

information about skin toxicity. 

DATES: The public workshop will be 

held on September 10, 2018, from 8:30 

a.m. to 4 p.m. Eastern Time. Submit 

either electronic or written comments 

on this public workshop by October 10, 

2018. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503, Section A), Silver Spring, 

MD 20993–0002. Entrance for the public 

workshop participants (non-FDA 

employees) is through Building 1, where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

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 October 10, 2018. The 


daltland on DSKBBV9HB2PROD with NOTICES
39762 Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of October 10, 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–2582 for ‘‘Human Dermal 

(Skin) Safety Testing for Topical Drug 

Products: Regulatory Utility and 

Evaluation; Public Workshop; Request 

for Comments.’’ 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: 

Tisha Washington, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–1019, 

tisha.washington@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a public 

workshop entitled ‘‘Human Dermal 

(Skin) Safety Testing for Topical Drug 

Products: Regulatory Utility and 

Evaluation’’ to discuss the current state 

and future directions of the collection of 

human data on the potential skin risks 

from use of topical drug products, 

including irritancy, sensitization, 

phototoxicity, and photoallergenicity. 

II. Topics for Discussion at the Public 

Workshop 

The morning session of the workshop 

will focus on review and discussion of 

current approaches for the collection of 

human skin toxicity data, limitations of 

these approaches, and their impact on 

labeling of topical drug products. The 

afternoon session of the workshop will 

be a panel discussion by individuals 

with different perspectives about 

alternative approaches to provide 

information about skin toxicity. Thirty 

minutes of the afternoon session will be 

allocated to an open public hearing. The 

Agency encourages health care 

providers, industry representatives, and 

other interested persons to attend this 

public workshop. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website by September 4, 2018: https:// 

www.eventbrite.com/e/fda-publicworkshop-human-dermal-safety-testingfor-topical-drug-products-tickets47483161414. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone, and 

intended attendance method—in person 

or by webcast. You may also indicate if 

you wish to present at the public 

comment session (see Requests for Oral 

Presentations). For those unable to 

attend in person, FDA will provide a 

live webcast of the workshop. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by 5 p.m. Eastern Time, 

September 4, 2018. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. Seating will be available on a 

first-come, first-served basis. If time and 

space permit, onsite registration on the 

day of the workshop will be provided 

beginning at 8:15 a.m. Eastern Time; 

FDA will let the public know whether 

onsite registration is available before the 

day of the public workshop. 

An agenda for the workshop and any 

other background materials will be 

made available 5 days before the 

workshop at https://www.fda.gov/ 

Drugs/NewsEvents/ucm611203.htm. 

If you need special accommodations 

due to a disability, please contact Tisha 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices 39763 

Washington, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1019, tisha.washington@

fda.hhs.gov no later than September 4, 

2018. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present at the 

public comment session, and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation. Following the close 

of registration, we will determine the 

amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

September 5, 2018. All requests to make 

oral presentations must be received by 

the close of registration on September 4, 

2018. If selected for presentation, any 

presentation materials must be emailed 

to Tisha Washington (see FOR FURTHER

INFORMATION CONTACT) no later than 

close of business, September 6, 2018. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast. The webcast link will 

be available on the following web page 

5 days before the workshop at: https:// 

www.fda.gov/Drugs/NewsEvents/ 

ucm611203.htm. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm611203.htm. 

Dated: August 6, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17130 Filed 8–9–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

HHS Approval of Entities That Certify 

Medical Review Officers 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: This notice publishes a list of 

the Department of Health and Human 

Services (HHS) approved Medical 

Review Officers certification entities. 

The HHS Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs (Mandatory Guidelines), 

applicable on October 1, 2017, 

addresses the role and qualifications of 

Medical Review Officers (MROs) and 

HHS approval of entities that certify 

MROs. 

FOR FURTHER INFORMATION CONTACT: 

Sean J. Belouin, Pharm.D., CAPT, 

United States Public Health Service, 

Senior Pharmacology and Regulatory 

Policy Advisor, Substance Abuse and 

Mental Health Services Administration, 

5600 Fishers Lane, Room 16N06D, 

Rockville, Maryland 20857; Telephone: 

(240) 276–2716; Email: sean.belouin@

samhsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: Subpart 

M—Medical Review Officer (MRO), 

Section 13.2 of the Mandatory 

Guidelines, ‘‘How are nationally 

recognized entities or subspecialty 

boards that certify MROs approved?’’ 

states as follows: ‘‘All nationally 

recognized entities or subspecialty 

boards which seek approval by the 

Secretary to certify physicians as MROs 

for federal workplace drug testing 

programs must submit their 

qualifications, a sample examination, 

and other necessary supporting 

examination materials (e.g., answers, 

previous examination statistics or other 

background examination information, if 

requested) (OMB Control No.: 0930– 

0158). Approval will be based on an 

objective review of qualifications that 

include a copy of the MRO applicant 

application form, documentation that 

the continuing education courses are 

accredited by a professional 

organization, and the delivery method 

and content of the examination. Each 

approved MRO certification entity must 

resubmit their qualifications for 

approval every two years. The Secretary 

shall publish at least every two years a 

notice in the Federal Register listing 

those entities and subspecialty boards 

that have been approved. This notice is 

also available on the internet at http:// 

www.samhsa.gov/workplace/drugtesting.’’ 

HHS has completed its review of 

entities that certify MROs, in 

accordance with requests submitted by 

such entities to HHS. 

The HHS Secretary approves the 

following MRO certifying entities that 

offer MRO certification through 

examination: 

American Association of Medical 

Review Officers (AAMRO), P.O. Box 

12873, Research Triangle Park, NC 

27709, Phone: (919) 489–5407, Fax: 

(919) 490–1010, Email: bbrandon@

aamro.com, website: http://

www.aamro.com/. 

Medical Review Officer Certification 

Council (MROCC), 3231 S. Halsted St, 

#167, Chicago, IL 60608, Phone: (847) 

631–0599, Fax: (847) 483–1282, 

Email: mrocc@mrocc.org, website: 

http://www.mrocc.org/. 

DATES: HHS approval is effective July 

31, 2018. 

Alex M. Azar II, 

Secretary. 

[FR Doc. 2018–17184 Filed 8–9–18; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council on Alcohol Abuse and 

Alcoholism. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 


daltland on DSKBBV9HB2PROD with NOTICES