Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32311 

one non-voting member who is 

identified with industry interests. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

BloodVaccinesandOtherBiologics/ 

AllergenicProductsAdvisoryCommittee/ 

ucm129360.htm or by contacting the 

Designated Federal Officer (see FOR

FURTHER INFORMATION CONTACT). In light 

of the fact that no change has been made 

to the committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: July 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14942 Filed 7–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2173] 

Long Term Follow-Up After 

Administration of Human Gene 

Therapy Products; Draft Guidance for 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 

document entitled ‘‘Long Term FollowUp After Administration of Human 

Gene Therapy Products; Draft Guidance 

for Industry.’’ The draft guidance 

provides sponsors, who are developing 

a human gene therapy (GT) product, 

recommendations regarding the design 

of long term follow-up (LTFU) 

observational studies for the collection 

of data on delayed adverse events 

following administration of a GT 

product. The draft guidance, when 

finalized, is intended to supersede the 

document entitled ‘‘Guidance for 

Industry: Gene Therapy Clinical 

Trials—Observing Participants for 

Delayed Adverse Events’’ dated 

November 2006. This draft guidance, 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Follow-up; Draft Guidance for 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.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 10, 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–2173 for ‘‘Long Term FollowUp After Administration of Human 

Gene Therapy Products; 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 Office 

of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 


amozie on DSK3GDR082PROD with NOTICES1
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