27782 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 

You may submit comments identified 

by Docket No. CDC–2018–0057 by either 

of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov (Follow the 

instructions for submitting comments). 

• U.S. Mail: Sam Tarr, Office of 

Safety, Security, and Asset Management 

(OSSAM), Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

MS–K80, Atlanta, Georgia 30329–4027. 

Instructions: All submissions must 

include the agency name and Docket 

Number. All relevant comments 

received will be posted to http://

www.regulations.gov (personally 

identifiable information, except for first 

and last names, will be redacted). For 

access to the docket to review 

background documents or comments 

received, go to http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Sam 

Tarr, Office of Safety, Security, and 

Asset Management (OSSAM), Centers 

for Disease Control and Prevention, 

1600 Clifton Road NE, MS–K80, Atlanta, 

Georgia 30329–4027, phone: (770) 488– 

8170, or email: cdc-macewv-eis@

cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Background: CDC is dedicated to 

protecting health and promoting quality 

of life through the prevention and 

control of disease, injury, and disability. 

NIOSH, one of CDC’s Centers, Institutes, 

and Offices, was established by the 

Occupational Safety and Health Act of 

1970. NIOSH plans, directs, and 

coordinates a national program to 

develop and establish recommended 

occupational safety and health 

standards, conduct research and 

training, provide technical assistance, 

and perform related activities to ensure 

safe and healthful working conditions 

for every working person in the United 

States. 

In 1997, NIOSH assumed the lease for 

a facility referred to as the Lake Lynn 

Experimental Mine (LLEM) when the 

mine safety and health function was 

transferred from the Bureau of Mines 

(BOM) to NIOSH. The LLEM facility had 

been leased by BOM since 1982. The 

LLEM was located 60 miles south of 

Pittsburgh, Pennsylvania. The LLEM 

and above ground fire testing facility 

was primarily used for studies and 

research on mine explosions, mine 

seals, mine rescue, ventilation, diesel 

exhaust, new health and safety 

technologies, ground control, and fire 

suppression. After December 2012, the 

property was no longer available for 

long-term leasing. CDC attempted to 

purchase the LLEM underlying 

property, but LLEM was vacated by the 

Government after market-based 

purchase offers were rejected by the 

property owners. 

In 2013, CDC completed a Project 

Development Study to outline a design 

solution for the replacement of the 

LLEM. The study presented the facility 

and site requirements and design 

concepts for the replacement facilities. 

In 2016, to identify potentially available 

locations that could accommodate the 

space requirements defined in the 2013 

study, GSA issued (on behalf of CDC) 

two separate Request for Expressions of 

Interest (REOI) for a site, developed or 

undeveloped, that could be used for the 

new underground safety research 

facility. The first REOI, advertised in 

June 2016, contained a limited 

delineated area within a 200-mile radius 

of the LLEM. The REOI set forth criteria 

that would be used to evaluate the 

suitability of the submitted sites. One 

expression of interest that had the 

potential to meet the minimum criteria 

was received. After further evaluation, 

however, the site was found to be nonviable. 

The second REOI was issued in 

October 2016 and expanded the 

delineated area to the contiguous United 

States. Three expressions of interest 

were received. One did not meet the 

minimum criteria, and a second 

expression of interest did not contain all 

necessary information to evaluate the 

offer. The offeror of the second site did 

not respond to subsequent GSA 

inquiries. 

The third potential site met the 

minimum criteria and was determined 

to be a viable site. The site is located 

near Mace, West Virginia, and straddles 

the Randolph and Pocahontas County 

lines. 

In accordance with NEPA, as 

implemented by the CEQ regulations (40 

CFR parts 1500–1508), CDC is initiating 

the preparation of an EIS for the 

proposed acquisition of the site and 

construction of a new underground 

safety research facility on the Site. 

Under NEPA, Federal agencies are 

required to evaluate the environmental 

effects of their proposed actions and a 

range of reasonable alternatives to the 

proposed action before making a 

decision. At a minimum, the EIS will 

evaluate the following two alternatives: 

The Proposed Action Alternative 

(acquisition of the Site and construction 

of a new underground safety research 

facility) and the No Action Alternative. 

Scoping Process: In accordance with 

NEPA, a public scoping process will be 

conducted to establish the range of 

issues to be addressed during the 

preparation of the EIS. Scoping is an 

early and open process for determining 

the scope of issues to be addressed and 

identifying issues that should be taken 

into account in selecting an alternative 

for implementation. To that end, during 

the scoping process, CDC will actively 

seek input from interested people; 

organizations; federally recognized 

Native American tribes; and federal, 

state, and regional agencies. 

The purpose of this Notice is to 

inform interested parties regarding 

CDC’s plan to prepare an EIS for the 

proposed Site acquisition in Mace, West 

Virginia, and the development of the 

Site into an underground safety research 

facility; to provide information on the 

nature of the Proposed Action; and to 

initiate the scoping process. The public 

scoping meeting will be held on June 

26, 2018, at the Linwood Community 

Library, 72 Snowshoe Drive, Slatyfork, 

West Virginia 26291, from 5:30 p.m. to 

8:30 p.m. Eastern Time. The public 

scoping meeting will be in open house 

format. General information on the Site 

and the Proposed Action will be 

provided, and representatives of CDC 

and GSA will be available to answer 

one-on-one questions. There will be no 

formal presentation or question-andanswer session. Participants may arrive 

at any time between 5:30 p.m. and 8:30 

p.m. Eastern Time. Comment forms will 

be provided for written comments, and 

a stenographer will be available to 

transcribe oral comments. Through the 

NEPA scoping process, CDC will also 

facilitate consultation with the public as 

required by Section 106 of the NHPA. 

Dated: June 7, 2018. 

Sandra Cashman, 

Executive Secretary Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–12660 Filed 6–13–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1918] 

Human Immunodeficiency Virus-1 

Infection: Developing Systemic Drug 

Products for Pre-Exposure 

Prophylaxis; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Human 

Immunodeficiency Virus-1 Infection: 

Developing Systemic Drug Products for 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 27783 

Pre-Exposure Prophylaxis.’’ This draft 

guidance provides nonclinical and 

clinical recommendations specific to the 

development of systemic drug products, 

with a focus on long-acting systemic 

drug products, regulated within the 

Center for Drug Evaluation and Research 

(CDER) at FDA for the prevention of 

sexually acquired human 

immunodeficiency virus-1 (HIV–1) 

infection. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 13, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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–D–1918 for ‘‘Human 

Immunodeficiency Virus-1 Infection: 

Developing Systemic Drug Products for 

Pre-Exposure Prophylaxis.’’ Received 

comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Struble, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6374, 

Silver Spring, MD 20993–0002, 301– 

794–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Human Immunodeficiency Virus-1 

Infection: Developing Systemic Drug 

Products for Pre-Exposure Prophylaxis.’’ 

This draft guidance provides 

nonclinical and clinical 

recommendations specific to the 

development of systemic drug products, 

with a focus on long-acting systemic 

drug products, regulated within CDER at 

FDA for the prevention of sexually 

acquired HIV–1 infection. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on developing systemic drug products 

for pre-exposure prophylaxis of HIV–1 

infection. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This draft guidance is 

not subject to Executive Order 12866. 

II. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

parts 312 and 314 have been approved 

under OMB control numbers 0910–0014 

and 0910–0001, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12761 Filed 6–13–18; 8:45 am] 

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