32312 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan McKnight, 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 

FDA is announcing the availability of 

a draft document entitled ‘‘Long Term 

Follow-Up After Administration of 

Human Gene Therapy Products; Draft 

Guidance for Industry.’’ The draft 

guidance provides a brief introduction 

of the product characteristics, patientrelated factors, and the preclinical and 

clinical data that should be considered 

when assessing the need for LTFU 

observations for your GT product. The 

draft guidance also describes the 

Agency’s current recommendations for 

the conduct of LTFU studies, 

specifically the information/data to 

support a sponsor’s rationale for the 

duration and design of a LTFU protocol 

when clinical trials are initiated. Also 

included in the draft guidance are GT 

product-specific clinical considerations 

for monitoring subjects under a LTFU 

protocol and recommendations on 

patient monitoring for licensed GT 

products. The draft guidance, when 

finalized, is intended to supersede the 

guidance entitled ‘‘Guidance for 

Industry: Gene Therapy Clinical 

Trials—Observing Participants for 

Delayed Adverse Events’’ dated 

November 2006. The draft guidance, 

when finalized, is also intended to 

supplement the guidance entitled 

‘‘Testing of Retroviral Vector-Based 

Human Gene Therapy Products for 

Replication Competent Retrovirus 

during Product Manufacture and Patient 

Follow-up; Draft Guidance for 

Industry,’’ published elsewhere in this 

issue of the Federal Register. Also, 

elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of another draft guidance 

entitled ‘‘Chemistry, Manufacturing, 

and Control Information for Human 

Gene Therapy Investigational New Drug 

Applications; Draft Guidance for 

Industry.’’ 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 long term follow-up after 

administration of human gene therapy 

products. 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 guidance is not 

subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

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 parts 50 and 

56 have been approved under OMB 

control number 0910–0755; the 

collections of information in 21 CFR 

part 58 have been approved under OMB 

control number 0910–0119; and the 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: July 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14867 Filed 7–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Committee on Heritable Disorders in 

Newborns and Children (ACHDNC) will 

hold a public meeting. 

DATES: Thursday, August 2, 2018, from 

9:30 a.m. to 5:00 p.m. Eastern Time 

(ET). 

ADDRESSES: This meeting is a webinar 

only and requires advanced registration. 

Please register online at http://

www.achdncmeetings.org/ by 12:00 p.m. 

ET on July 30, 2018. 

FOR FURTHER INFORMATION CONTACT: Ann 

Ferrero, Maternal and Child Health 

Bureau (MCHB), HRSA, in one of three 

ways: (1) Send a request to the following 

address: Ann Ferrero, MCHB, HRSA 

5600 Fishers Lane, Room 18N100C, 

Rockville, MD 20857; (2) call 301–443– 

3999; or (3) send an email to AFerrero@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Background: The ACHDNC provides 

advice and recommendations to the 

Secretary of HHS on the development of 

newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. In addition, 

ACHDNC’s recommendations regarding 

inclusion of additional conditions for 

screening, following adoption by the 

Secretary, are evidence-informed 

preventive health services provided for 

in the comprehensive guidelines 

supported by HRSA through the 

Recommended Uniform Screening Panel 

(RUSP) pursuant to section 2713 of the 

Public Health Service Act (42 U.S.C. 

300gg–13). Under this provision, nongrandfathered group health plans and 

health insurance issuers offering group 

or individual health insurance are 

required to provide insurance coverage 

without cost-sharing (a co-payment, coinsurance, or deductible) for preventive 

services for plan years (i.e., policy years) 

beginning on or after the date that is one 

year from the Secretary’s adoption of the 

condition for screening. 

Agenda: During the August 2, 2018, 

meeting, the ACHDNC will discuss 

issues related to long-term follow-up, 

timeliness, education and training, the 

evidence-based review process, and risk 

assessment in newborn screening. 

Information about the ACHDNC, a roster 

of members, and the meeting agenda, as 

well as past meeting summaries, is 

located on the ACHDNC website: 

https://www.hrsa.gov/advisorycommittees/heritable-disorders/ 

index.html. 

Public Participation: Members of the 

public will have the opportunity to 

provide comments, which are part of the 

official Committee record. To submit 

written comments or request time 

for an oral comment at the meeting, 

please register online by 12:00 p.m. ET 

on July 27, 2018, at http://

www.achdncmeetings.org. Oral 

comments will be honored in the order 

they are requested and may be limited 

as time allows. Individuals associated 

with groups or who plan to provide 

comments on similar topics may be 

asked to combine their comments and 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32313 

present them through a single 

representative. No audiovisual 

presentations are permitted. Written 

comments should identify the 

individual’s name, address, email, 

telephone number, professional or 

organization affiliation, background or 

area of expertise (i.e., parent, family 

member, researcher, clinician, public 

health, etc.) and the topic/subject 

matter. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–14908 Filed 7–11–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of 

meetings of the National Center for 

Advancing Translational Sciences. 

The meetings 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 meetings 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, 

and personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Cures Acceleration 

Network Review Board. 

Date: September 27, 2018. 

Time: 8:30 a.m. to 3:00 p.m. 

Agenda: Report from the Institute Director. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Anna L. Ramsey-Ewing, 

Ph.D., Executive Secretary, National Center 

for Advancing Translational Sciences, 1 

Democracy Plaza, Room 1072, Bethesda, MD 

20892, 301–435–0809, annn.ramseyewing@

nih.gov. 

Name of Committee: National Center for 

Advancing Translational Sciences Advisory 

Council. 

Date: September 27, 2018. 

Open: 8:30 a.m. to 3:00 p.m. 

Agenda: Report from the Institute Director 

and other staff. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Closed: 3:15 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Anna L. Ramsey-Ewing, 

Ph.D., Executive Secretary, National Center 

for Advancing Translational Sciences, 1 

Democracy Plaza, Room 1072, Bethesda, MD 

20892, 301–435–0809, anna.ramseyewing@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: July 5, 2018. 

David D. Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–14873 Filed 7–11–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Integrative Health; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the ZAT1 PJ (02) 

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, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Complementary and Integrative Health 

Special Emphasis Panel; Mechanisms of 

Mind and Body Interventions (MMB). 

Date: August 1, 2018. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Pamela Eugenia Jeter, 

Ph.D., Scientific Review Officer, Office of 

Scientific Review, Division of Extramural 

Activities, NCCIH, NIH, 6707 Democracy 

Boulevard, Suite 401, Bethesda, MD 20892, 

301–435–2591, pamela.jeter@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Integrative Health, 

National Institutes of Health, HHS) 

Dated: July 6, 2018. 

Michelle D. Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–14874 Filed 7–11–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of Saybolt 

LP (Nederland, TX) as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of Saybolt LP (Nederland, TX) 

as a commercial gauger and laboratory. 

SUMMARY: Notice is hereby given, 

pursuant to CBP regulations, that 

Saybolt LP (Nederland, TX) has been 

approved to gauge petroleum and 

certain petroleum products and 

accredited to test petroleum and certain 

petroleum products for customs 

purposes for the next three years as of 

August 8, 2017. 

DATES: Saybolt LP (Nederland, TX) was 

approved and accredited as a 

commercial gauger and laboratory as of 

August 8, 2017. The next triennial 

inspection date will be scheduled for 

August 2020. 

FOR FURTHER INFORMATION CONTACT: 

Christopher J. Mocella, Laboratories and 

Scientific Services Directorate, U.S. 

Customs and Border Protection, 1300 

Pennsylvania Avenue NW, Suite 1500N, 

Washington, DC 20229, tel. 202–344– 

1060. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given pursuant to 19 CFR 151.12 

and 19 CFR 151.13, that Saybolt LP, 

4144 N Twin City Hwy., Nederland, TX 

77627, has been approved to gauge 

petroleum and certain petroleum 

products and accredited to test 

petroleum and certain petroleum 

products for customs purposes, in 

accordance with the provisions of 19 

CFR 151.12 and 19 CFR 151.13. Saybolt 


amozie on DSK3GDR082PROD with NOTICES1