Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32309 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1999–D–0081] 

Testing of Retroviral Vector-Based 

Human Gene Therapy Products for 

Replication Competent Retrovirus 

During Product Manufacture and 

Patient Follow-up; Draft Guidance for 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 ‘‘Testing of Retroviral 

Vector-Based Human Gene Therapy 

Products for Replication Competent 

Retrovirus During Product Manufacture 

and Patient Follow-up; Draft Guidance 

for Industry.’’ The draft guidance 

document provides sponsors of 

retroviral vector-based human gene 

therapy products recommendations 

regarding the testing for replication 

competent retrovirus (RCR) during the 

manufacture of retroviral vector-based 

products, and during follow-up 

monitoring of patients who have 

received retroviral vector-based 

products. Recommendations include the 

identification and amount of material to 

be tested, and general testing methods. 

In addition, recommendations are 

provided on monitoring patients for 

evidence of retroviral infection after 

administration of retroviral vector-based 

gene therapy products. The draft 

guidance, when finalized, is intended to 

supersede the document entitled 

‘‘Guidance for Industry: Supplemental 

Guidance on Testing for Replication 

Competent Retrovirus in Retroviral 

Vector Based Gene Therapy Products 

and During Follow-up of Patients in 

Clinical Trials Using Retroviral 

Vectors,’’ dated November 2006. The 

draft guidance, when finalized, is also 

intended to supplement the documents 

entitled ‘‘Long Term Follow-Up After 

Administration of Human Gene Therapy 

Products; Draft Guidance for Industry’’ 

and ‘‘Chemistry, Manufacturing, and 

Control Information for Human Gene 

Therapy Investigational New Drug 

Applications; Draft Guidance for 

Industry,’’ when these draft guidance 

documents are finalized. 

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written comments on the draft guidance 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draft guidance before it begins work on 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– 

1999–D–0081 for ‘‘Testing of Retroviral 

Vector-Based Human Gene Therapy 

Products for Replication Competent 

Retrovirus During Product Manufacture 

and Patient Follow-up; 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 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Segal, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 


amozie on DSK3GDR082PROD with NOTICES1
32310 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document 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.’’ The draft 

guidance document provides sponsors 

of retroviral vector-based human gene 

therapy products recommendations 

regarding the testing for RCR during the 

manufacture of retroviral vector-based 

products, and during follow-up 

monitoring of patients who have 

received retroviral vector-based 

products. Recommendations are also 

provided for RCR testing during 

manufacture, including identification 

and amount of material to be tested, and 

general testing methods. In addition, 

recommendations are provided on 

monitoring patients for evidence of 

retroviral infection after administration 

of retroviral vector-based gene therapy 

products. The draft guidance, when 

finalized, is intended to supersede the 

document entitled ‘‘Guidance for 

Industry: Supplemental Guidance on 

Testing for Replication Competent 

Retrovirus in Retroviral Vector Based 

Gene Therapy Products and During 

Follow-up of Patients in Clinical Trials 

Using Retroviral Vectors,’’ dated 

November 2006. The draft guidance, 

when finalized, is also intended to 

supplement the ‘‘Long Term Follow-Up 

After Administration of Human Gene 

Therapy Products; Draft Guidance for 

Industry’’ and ‘‘Chemistry, 

Manufacturing, and Control Information 

for Human Gene Therapy 

Investigational New Drug Applications; 

Draft Guidance for Industry,’’ when 

these draft guidance documents are 

finalized. Elsewhere in this issue of the 

Federal Register, FDA is announcing 

the availability of these other two draft 

guidance documents. 

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 FDA’s current thinking on 

testing of retroviral vector-based human 

gene therapy products for replication 

competent retrovirus during product 

manufacture and patient follow-up. 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 

The 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 part 312 have 

been approved under OMB control 

number 0910–0014; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

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. 2018–14868 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–N–2475] 

Advisory Committee; Allergenic 

Products Advisory Committee; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Allergenic Products 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Allergenic 

Products Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until July 9, 2020. 

DATES: Authority for the Allergenic 

Products Advisory Committee expired 

on July 9, 2018; however, the 

Commissioner formally determined that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Serina Hunter-Thomas, Division of 

Scientific Advisors and Consultants, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 6338, Silver Spring, 

MD 20993–0002; 240–402–5771, 

serina.hunter-thomas@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Allergenic Products Advisory 

Committee. The committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

available data concerning the safety, 

effectiveness, and adequacy of labeling 

of marketed and investigational 

allergenic biological products or 

materials that are administered to 

humans for the diagnosis, prevention, or 

treatment of allergies and allergic 

disease, and makes appropriate 

recommendations to the Commissioner 

of its findings regarding the affirmation 

or revocation of biological product 

licenses; on the safety, effectiveness, 

and labeling of the products; on clinical 

and laboratory studies of such products; 

on amendments or revisions to 

regulations governing the manufacture, 

testing, and licensing of allergenic 

biological products; and on the quality 

and relevance of FDA’s research 

programs that provide the scientific 

support for regulating these agents. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of allergy, 

immunology, pediatrics, internal 

medicine, biochemistry, and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Almost all non-Federal members 

of this committee serve as Special 

Government Employees. The core of 

voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 


amozie on DSK3GDR082PROD with NOTICES1