Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45455 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

III. Paperwork Reduction Act 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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 101.36 have 

been approved under OMB control 

number 0910–0381. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19367 Filed 9–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Charter Renewal for the Advisory 

Committee on Organ Transplantation 

AGENCY: Health Resources and Services 

Administration (HRSA), The 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of charter renewal. 

SUMMARY: HHS is hereby giving notice 

that the Advisory Committee on Organ 

Transplantation (ACOT) has been 

rechartered. The effective date of the 

renewed charter is August 31, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Robert Walsh, Executive Secretary, 

Advisory Committee on Organ 

Transplantation, Health Resources and 

Services Administration, Department of 

Health and Human Services, Room 

08W60, 5600 Fishers Lane, Rockville, 

Maryland 20857. Phone: (301) 443– 

6839; fax: (301) 594–6095; email: 

rwalsh@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The ACOT 

was authorized by section 121.12 of the 

amended Final Rule of the Organ 

Procurement and Transplantation 

Network (OPTN) (42 CFR part 121). In 

accordance with the Federal Advisory 

Committee Act (FACA), Public Law 92– 

463, it was initially chartered on 

September 1, 2000, and was renewed at 

the appropriate intervals. 

The ACOT provides advice to the 

Secretary on all aspects of organ 

donation, procurement, allocation, and 

transplantation, and on such other 

matters that the Secretary determines. 

The recommendations of the ACOT will 

facilitate the Department’s efforts to 

oversee the Organ Procurement and 

Transplantation Network (OPTN), as set 

forth in the National Organ Transplant 

Act of 1984, as amended. 

The charter renewal for the ACOT 

was approved on August 31, 2018, 

which will also stand as the filing date. 

Renewal of the ACOT charter gives 

authorization for the Committee to 

operate until August 31, 2020. 

A copy of the ACOT charter is 

available on the ACOT website at: 

http://www.organdonor.gov/legislation/ 

advisory.html. A copy of the charter can 

also be obtained by accessing the FACA 

database that is maintained by the 

Committee Management Secretariat 

under the General Services 

Administration. The website for the 

FACA database is http://

www.facadatabase.gov/. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–19454 Filed 9–6–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Responsibility of 

Applicants for Promoting Objectivity in 

Research for Which Public Health 

Service (PHS) Funding is Sought and 

Responsible Prospective Contractors 

(Office of the Director) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

ADDRESSES: Written comments and/or 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time, should be 

directed to the: Office of Management 

and Budget, Office of Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Ms. Diane Dean, 

Director, Division of Grants Compliance 

and Oversight, Office of Policy for 

Extramural Research Administration, 

Office of Extramural Research, National 

Institutes of Health, 6705 Rockledge 

Drive, Room 3525, Bethesda, MD 20892, 

or call non-toll-free number (301) 435– 

0930 or Email your request, including 

your address to: deand@

od31em1.od.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on March 16, 2018, (FR 83 

pages 11763–11765) and allowed 60 

days for public comment. One public 

comment was received. The purpose of 

this notice is to allow an additional 30 

days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. 

Proposed Collection: Responsibility of 

Applicants for Promoting Objectivity in 

Research for which Public Health 

Service (PHS) Funding is Sought 42 CFR 

part 50 subpart F and Responsible 

Prospective Contractors 45 CFR part 94, 

0925–0417, expiration date 2/28/2015, 

REINSTATEMENT WITHOUT 

CHANGE, Office of Policy for 

Extramural Research Administration 

(OPERA), Office of Extramural Research 

(OER), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: This request is for Office of 

Management and Budget (OMB) 

approval of a Reinstatement Without 

Change of a currently approved 

collection resulting from the 

development of revised regulations 

regarding the Responsibility of 

Applicants for Promoting Objectivity in 

Research for which PHS Funding is 

Sought (42 CFR part 50, subpart F) and 

Responsible Prospective Contractors (45 

CFR part 94). The purpose of these 

regulations is to promote objectivity in 

research by requiring institutions to 

establish standards to ensure that there 

is no reasonable expectation that the 

design, conduct, or reporting of PHSVerDate Sep<11>2014 17:55 Sep 06, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1

daltland on DSKBBV9HB2PROD with NOTICES
45456 Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 

funded research will be biased by any 

Investigator Financial Conflict of 

Interest (FCOI). 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

677,820. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents based on applicable 

section of regulation Number of respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total annual 

burden hours 

Reporting: 

Initial Reports under 42 CFR 50.605(b)(1) and (b)(3) 

or 45 CFR 94.5(b)(1) and (b)(3) from awardee Institutions.

992 ............................................... 1 2 1,984 

Subsequent Reports under 42 CFR 50.605(a)(3)(iii) 

and (b)(2) or 45 CFR 94.5(a)(3)(iii) and (b)(2) from 

awardee Institutions.

50 FCOI reports as in 42 CFR 

50.605(a)(3)(ii) and 45 CFR 

94.5(a)(3)(ii).

1 2 100 

5 Mitigation Reports ..................... 1 2 10 

Annual Report under 42 CFR 50.605(b)(4) or 45 

CFR 94.5(b)(4) from awardee Institutions.

2,031 ............................................ 1 1 2,031 

Subsequent Reports under 42 CFR 50.606(a) or 45 

CFR 94.6 from awardee Institutions.

20 ................................................. 1 10 200 

Record Keeping: 

Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from 

awardee institutions.

2,000 ............................................ 1 4 8,000 

Disclosure: 

Under 42 CFR 50.604(a) or 45 CFR 94.4 for Investigators.3,000 ............................................ 1 81 243,000 

Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for 

Investigators.

38,000 .......................................... 1 30/60 19,000 

Under 42 CFR 50.604(b) or 45 CFR 94.4 (e)(1) for 

Institutions.

2,000 ............................................ 1 6 12,000 

Under 42 CFR 50.604(c)(1) or 45 CFR 94.4(c)(1) 

from subrecipients.

500 ............................................... 1 1 500 

Under 42 CFR 50.604(d) or 45 CFR 94.4 for Institutions.3,000 1 .......................................... 1 1 3,000 

Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) 

for Investigators.

38,000 .......................................... 1 4 152,000 

Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) 

for Investigators.

38,000 .......................................... 1 1 38,000 

Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) 

for Investigators.

992 ............................................... 1 30/60 496 

Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions.2,000 ............................................ 1 1 2,000 

Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) 

for Institutions.

2,000 2 .......................................... 1 82 164,000 

Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) 

for Institutions.

500 3 ............................................. 1 3 1,500 

Under 42 CFR 50.605(a)(3)(i) or 45 CFR 

94.5(a)(3)(i).

50 4 ............................................... 1 80 4,000 

Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 

94.5(a)(3)(ii).

50 5 ............................................... 1 80 4,000 

Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 

94.5(a)(3)(iii).

50 ................................................. 1 1 50 

Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4) .... 992 ............................................... 1 12 11,904 

Public Website Posting under 42 CFR 50.605(a)(5) 

or 45 CFR 94.5(a)(5) from awardee Institutions.

2,000 ............................................ 1 5 10,000 

Under 42 CFR 50.606(c) or 45 CFR 94.6(c) ............. 50 6 ............................................... 7 3 18/60 45 

Total .................................................................... 136,282 ........................................ 136,382 ........................ 677,820 

1Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all Investigators. 

2Although an estimated 992 reports of Conflict of Interest are expected annually, the 2,000 responding Institutions must review all financial disclosures associated with PHS-funded awards to determine whether any conflicts of interest exist. Thus, the review burden of 76,000 hours is 

based upon estimates that it will take on the average 2 hours for an institutional official(s) to review each of 38,000 financial disclosures associated with PHS funded awards. The burden for developing a management plan for identified FCOI is estimated at 80 hours × 992 cases = 79,360 

hours. 3Assuming that this is a rare occurrence based on prior experience. 

4Assuming only a fraction of the newly identified SFIs will constitute FCOI. 

5Assuming only a fraction of the newly identified SFIs will constitute FCOI. 

6 Number based on 50.605/94.5(a)(3)(i)—of those only a fraction will relate to a project of clinical research whose purpose is to evaluate the 

safety or effectiveness of a drug, medical device, or treatment, but we are calculating the maximum estimated burden. 7Assuming an average of 3 publications annually. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45457 

Dated: August 30, 2018. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2018–19339 Filed 9–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2018–0791] 

Information Collection Request to 

Office of Management and Budget; 

OMB Control Number: 1625–0018 

AGENCY: Coast Guard, DHS. 

ACTION: Sixty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

U.S. Coast Guard intends to submit an 

Information Collection Request (ICR) to 

the Office of Management and Budget 

(OMB), Office of Information and 

Regulatory Affairs (OIRA), requesting an 

extension of its approval for the 

following collection of information: 

1625–0018, Official Logbook; without 

change. Our ICR describes the 

information we seek to collect from the 

public. Before submitting this ICR to 

OIRA, the Coast Guard is inviting 

comments as described below. 

DATES: Comments must reach the Coast 

Guard on or before November 6, 2018. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2108–0791] to the Coast 

Guard using the Federal eRulemaking 

Portal at http://www.regulations.gov. 

See the ‘‘Public participation and 

request for comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

A copy of the ICR is available through 

the docket on the internet at http://

www.regulations.gov. Additionally, 

copies are available from: Commandant 

(CG–612), Attn: Paperwork Reduction 

Act Manager, U.S. Coast Guard, 2703 

Martin Luther King Jr. Ave. SE, Stop 

7710, Washington, DC 20593–7710. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Anthony Smith, Office of Information 

Management, telephone 202–475–3532, 

or fax 202–372–8405, for questions on 

these documents. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

This Notice relies on the authority of 

the Paperwork Reduction Act of 1995; 

44 U.S.C. Chapter 35, as amended. An 

ICR is an application to OIRA seeking 

the approval, extension, or renewal of a 

Coast Guard collection of information 

(Collection). The ICR contains 

information describing the Collection’s 

purpose, the Collection’s likely burden 

on the affected public, an explanation of 

the necessity of the Collection, and 

other important information describing 

the Collection. There is one ICR for each 

Collection. 

The Coast Guard invites comments on 

whether this ICR should be granted 

based on the Collection being necessary 

for the proper performance of 

Departmental functions. In particular, 

the Coast Guard would appreciate 

comments addressing: (1) The practical 

utility of the Collection; (2) the accuracy 

of the estimated burden of the 

Collection; (3) ways to enhance the 

quality, utility, and clarity of 

information subject to the Collection; 

and (4) ways to minimize the burden of 

the Collection on respondents, 

including the use of automated 

collection techniques or other forms of 

information technology. In response to 

your comments, we may revise this ICR 

or decide not to seek an extension of 

approval for the Collection. We will 

consider all comments and material 

received during the comment period. 

We encourage you to respond to this 

request by submitting comments and 

related materials. Comments must 

contain the OMB Control Number of the 

ICR and the docket number of this 

request, [USCG–2018–0791], and must 

be received by November 6, 2018. 

Submitting Comments 

We encourage you to submit 

comments through the Federal 

eRulemaking Portal at http://

www.regulations.gov. If your material 

cannot be submitted using http://

www.regulations.gov, contact the person 

in the FOR FURTHER INFORMATION

CONTACT section of this document for 

alternate instructions. Documents 

mentioned in this notice, and all public 

comments, are in our online docket at 

http://www.regulations.gov and can be 

viewed by following that website’s 

instructions. Additionally, if you go to 

the online docket and sign up for email 

alerts, you will be notified when 

comments are posted. 

We accept anonymous comments. All 

comments received will be posted 

without change to http://

www.regulations.gov and will include 

any personal information you have 

provided. For more about privacy and 

the docket, you may review a Privacy 

Act notice regarding the Federal Docket 

Management System in the March 24, 

2005, issue of the Federal Register (70 

FR 15086). 

Information Collection Request 

Title: Official Logbook. 

OMB Control Number: 1625–0018. 

Summary: The Official Logbook 

contains information about the voyage, 

the vessel’s crew, drills, watches, and 

operations conducted during the 

voyage. Official Logbook entries identify 

particulars of the voyage, including the 

name of the ship, official number, port 

of registry, tonnage, names and 

merchant mariner credential numbers of 

the master and crew, the nature of the 

voyage, and class of ship. In addition, it 

also contains entries for the vessel’s 

drafts, maintenance of watertight 

integrity of the ship, drills and 

inspections, crew list and report of 

character, a summary of laws applicable 

to Official Logbooks, and miscellaneous 

entries. 

Need: Title 46 U.S.C. 11301, 11302, 

11303, and 11304 require applicable 

merchant vessels to maintain an Official 

Logbook. The Official Logbook contains 

information about the vessel, voyage, 

crew, and watch. Lack of these 

particulars would make it difficult for a 

seaman to verify vessel employment and 

wages, and for the Coast Guard to verify 

compliance with laws and regulations 

concerning vessel operations and safety 

procedures. The Official Logbook serves 

as an official record of recordable events 

transpiring at sea such as births, deaths, 

marriages, disciplinary actions, etc. 

Absent the Official Logbook, there 

would be no official civil record of these 

events. The courts accept log entries as 

proof that the logged event occurred. If 

this information was not collected, the 

Coast Guard’s commercial vessel safety 

program would be negatively impacted, 

as there would be no official record of 

U.S. merchant vessel voyages. Similarly, 

those seeking to prove that an event 

required to be logged occurred would 

not have an official record available. 

Forms: CG–706B, Official Logbook. 

Respondents: Shipping companies. 

Frequency: On occasion. 

Hour Burden Estimate: The estimated 

annual burden remains at 1,750 hours a 

year. 

Authority: The Paperwork Reduction Act 

of 1995; 44 U.S.C. Chapter 35, as amended. 

Dated: August 30, 2018. 

James D. Roppel, 

U.S. Coast Guard, Acting Chief, Office of 

Information Management. 

[FR Doc. 2018–19412 Filed 9–6–18; 8:45 am] 

BILLING CODE 9110–04–P 


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