Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44273 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat Division (MVCB), 

1800 F Street NW, Washington, DC 

20405, telephone 202–501–4755. Please 

cite OMB Control No. 3090–0112, GSA 

Form 3040, State Agency Monthly 

Donation Report of Surplus Personal 

Property, in all correspondence. 

Dated: August 22, 2018. 

David A. Shive, 

Chief Information Officer. 

[FR Doc. 2018–18788 Filed 8–29–18; 8:45 am] 

BILLING CODE 6820–34–P 

GENERAL SERVICES 

ADMINISTRATION 

[OMB Control No. 3090–0014; Docket No. 

2018–0001; Sequence No. 7] 

Information Collection; Transfer 

Order—Surplus Personal Property and 

Continuation Sheet, Standard Form 

(SF) 123 

AGENCY: Federal Acquisition Service, 

General Services Administration (GSA). 

ACTION: Notice of request for an 

extension to an existing OMB clearance. 

SUMMARY: Under the provisions of the 

Paperwork Reduction Act, the 

Regulatory Secretariat Division will be 

submitting to the Office of Management 

and Budget (OMB) a request to review 

and approve an extension of a 

previously approved information 

collection requirement regarding the 

Transfer Order—Surplus Personal 

Property and Continuation Sheet, 

Standard Form (SF) 123. 

DATES: Submit comments on or before: 

October 29, 2018. 

ADDRESSES: Submit comments 

identified by Information Collection 

3090–0014, Transfer Order—Surplus 

Personal Property and Continuation 

Sheet, Standard Form (SF) 123, by any 

of the following methods: 

• Regulations.gov: http://

www.regulations.gov. 

Submit comments via the Federal 

eRulemaking portal by searching the 

OMB control number. Select the link 

‘‘Comment Now’’ that corresponds with 

‘‘Information Collection 3090–0014, 

Transfer Order—Surplus Personal 

Property and Continuation Sheet, 

Standard Form (SF) 123’’. Follow the 

instructions provided on the screen. 

Please include your name, company 

name (if any), and ‘‘Information 

Collection 3090–0014, Transfer Order— 

Surplus Personal Property and 

Continuation Sheet, Standard Form (SF) 

123,’’ on your attached document. 

• Mail: General Services 

Administration, Regulatory Secretariat 

Division (MVCB), 1800 F Street NW, 

Washington, DC 20405. ATTN: Ms. 

Mandell/IC 3090–0014. 

Instructions: Please submit comments 

only and cite Information Collection 

3090–0014, Transfer Order—Surplus 

Personal Property and Continuation 

Sheet, Standard Form (SF) 123, in all 

correspondence related to this 

collection. All comments received will 

be posted without change to http://

www.regulations.gov, including any 

personal and/or business confidential 

information provided. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Christopher Willett, Property Disposal 

Specialist, GSA Office of Personal 

Property Management, at telephone 

703–605–2873 or via email to 

christopher.willett@gsa.gov. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The Transfer Order—Surplus Personal 

Property and Continuation Sheet, 

Standard form (SF) 123, is used by a 

State Agency for Surplus Property 

(SASP) to donate Federal surplus 

personal property to public agencies, 

nonprofit educational or public health 

activities, programs for the elderly, 

service educational activities, and 

public airports. The SF 123 serves as the 

transfer instrument and includes item 

descriptions, transportation 

instructions, nondiscrimination 

assurances, and approval signatures. 

B. Annual Reporting Burden 

Respondents (electronic): 30,890. 

Respondents (manual): 312. 

Total Number of Respondents: 31,202. 

Total Hours per Response (electronic 

at .017 Hours per Response): 525.13. 

Total Hours per Response (manual at 

.13 Hours per Response): 40.56. 

Total Burden Hours: 565.69. 

C. Public Comments 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary and whether it 

will have practical utility; whether our 

estimate of the public burden of this 

collection of information is accurate, 

and based on valid assumptions and 

methodology; ways to enhance the 

quality, utility, and clarity of the 

information to be collected. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat Division (MVCB), 

1800 F Street NW, Washington, DC, 

20405, telephone 202–501–4755. Please 

cite OMB Control No. 3090–0014, 

Transfer Order—Surplus Personal 

Property and Continuation Sheet, 

Standard Form (SF) 123, in all 

correspondence. 

Dated: August 22, 2018. 

David A. Shive, 

Chief Information Officer. 

[FR Doc. 2018–18790 Filed 8–29–18; 8:45 am] 

BILLING CODE 6820–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1041] 

Development of a Shared System Risk 

Evaluation and Mitigation Strategy; 

Draft Guidance for Industry; 

Availability; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; reopening 

of the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period for the 

notice of availability for ‘‘Development 

of a Shared System Risk Evaluation and 

Mitigation Strategy; Draft Guidance for 

Industry,’’ published in the Federal 

Register of June 1, 2018. The Agency 

has received a request for an extension 

of the comment period for the draft 

guidance. 

DATES: FDA is reopening the comment 

period on the notice of availability 

published June 1, 2018 (83 FR 25468). 

Submit either electronic or written 

comments on the draft guidance by 

September 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, 


amozie on DSK3GDR082PROD with NOTICES1
44274 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 

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–1041 for ‘‘Development of a 

Shared System Risk Evaluation and 

Mitigation Strategy; Draft Guidance for 

Industry.’’ 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: 

Lubna Merchant, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4418, 

Silver Spring, MD 20993–0002, 301– 

796–5162, email: Lubna.Merchant@

fda.hhs.gov; or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 1, 2018 

(83 FR 25468), FDA published a notice 

of availability with a 60-day comment 

period to request comments on the draft 

guidance for industry entitled 

‘‘Development of a Shared System Risk 

Evaluation and Mitigation Strategy.’’ 

The Agency has received a request for 

an extension of the comment period for 

the draft guidance. FDA has considered 

the request and is reopening the 

comment period for the draft guidance 

until September 13, 2018. The Agency 

believes that a 14-day reopening of the 

comment period allows adequate time 

for interested persons to submit 

comments to ensure that the Agency can 

consider the comments on this draft 

guidance before it begins work on the 

final version of the guidance. 

II. 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: August 23, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18775 Filed 8–29–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0049] 

Complex Innovative Designs Pilot 

Meeting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The sixth iteration of the 

Prescription Drug User Fee Act (PDUFA 

VI), incorporated as part of the FDA 

Reauthorization Act of 2017 (FDARA), 

highlights the goal of facilitating and 

advancing the use of complex adaptive, 

Bayesian, and other novel clinical trial 

designs. The Food and Drug 

Administration (FDA or Agency) is 

announcing a pilot meeting program 

that affords sponsors who are selected 

the opportunity to meet with Agency 

staff to discuss the use of complex 

innovative trial design (CID) approaches 

in medical product development. 

Meetings under the pilot program will 

be conducted by FDA’s Center for Drug 

Evaluation and Research (CDER) or 

Center for Biologics Evaluation and 

Research (CBER) during fiscal years 

2018 to 2022. This pilot meeting 

program fulfills FDA’s commitment 

under PDUFA VI. For each sponsor 

whose meeting request is granted as part 

of the pilot, FDA will grant two 

meetings between the sponsor and 

CDER or CBER that will provide an 

opportunity for medical product 

developers and FDA to discuss 

regulatory approaches for CID. To 

promote innovation in this area, trial 

designs developed through the pilot 

meeting program may be presented by 

FDA (e.g., in a guidance or public 

workshop) as case studies, including 


amozie on DSK3GDR082PROD with NOTICES1