Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45249 

part 822 have been approved under 

OMB control number 0910–0449. 

Dated: August 30, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19249 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3233] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Technical Electronic 

Product Radiation Safety Standards 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Technical Electronic Product 

Radiation Safety Standards Committee 

(TEPRSSC) in the Center for Devices 

and Radiological Health. Nominations 

will be accepted for current and 

upcoming vacancies effective with this 

notice. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Nominations received on or 

before November 5, 2018 will be given 

first consideration for membership on 

TEPRSSC. Nominations received after 

November 5, 2018 will be considered for 

nomination to the committee as later 

vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by accessing FDA’s 

Advisory Committee Membership 

Nomination Portal at https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Patricio G. Garcia, Office of Device 

Evaluation, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G610, Silver Spring, 

MD 20993–0002, 301–796–6875, email: 

Patricio.Garcia@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members on TEPRSSC that include 

three general public representatives. 

I. General Description of the 

Committee’s Duties 

The committee provides advice and 

consultation to the Commissioner of 

Food and Drugs (Commissioner) on the 

technical feasibility, reasonableness, 

and practicability of performance 

standards for electronic products to 

control the emission of radiation from 

such products, and may recommend 

electronic product radiation safety 

standards to the Commissioner for 

consideration. 

II. Criteria for Voting Members 

The committee consists of a core of 15 

voting members including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among authorities knowledgeable in the 

fields of science or engineering, 

applicable to electronic product 

radiation safety. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Terms of more than 2 

years are contingent upon the renewal 

of the committee by appropriate action 

prior to its expiration. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the committee. Selfnominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address and/or home address, 

telephone number, and email address if 

available, and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19355 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–1999–D–0081, FDA– 

2008–D–0205, FDA–2018–D–2173, FDA– 

2018–D–2236, FDA–2018–D–2238, and FDA– 

2018–D–2258] 

Draft Guidances Relating to the 

Development of Human Gene Therapy 

Products; Availability; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notices of availability for six draft 

guidance documents relating to the 

development of human gene therapy 

products that appeared in the Federal 

Register of July 12, 2018. The Agency is 

taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments and any new 

information. 

DATES: FDA is extending the comment 

period on the six documents that 

published on July 12, 2018 (see 

SUPPLEMENTARY INFORMATION). Submit 

either electronic or written comments 

by December 10, 2018, to ensure that the 

Agency considers your comment on 

these draft guidances before it begins 

work on the final version of the 

guidances. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 10, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 10, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 


daltland on DSKBBV9HB2PROD with NOTICES
45250 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

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;’’ Docket No. FDA–2008–D– 

0205 for ‘‘Chemistry, Manufacturing, 

and Control Information for Human 

Gene Therapy Investigational New Drug 

Applications; Draft Guidance for 

Industry;’’ Docket No. FDA–2018–D– 

2173 for ‘‘Long Term Follow-Up After 

Administration of Human Gene Therapy 

Products; Draft Guidance for Industry;’’ 

Docket No. FDA–2018–D–2236 for 

‘‘Human Gene Therapy for Retinal 

Disorders; Draft Guidance for Industry;’’ 

Docket No. FDA–2018–D–2238 for 

‘‘Human Gene Therapy for Hemophilia; 

Draft Guidance for Industry;’’ or Docket 

No. FDA–2018–D–2258 for ‘‘Human 

Gene Therapy for Rare Diseases; Draft 

Guidance for Industry.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Jenifer Stach, 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 July 12, 

2018, FDA published notices of 

availability with a 90-day comment 

period for six draft guidance documents 

listed in the following table. Three of 

the six draft guidance documents 

provide recommendations to 

stakeholders developing gene therapies 

for retinal disorders, hemophilia, and 

rare diseases. The remaining three 

guidance documents provide 

recommendations to sponsors 

manufacturing gene therapies; namely, 

how to provide chemistry, 

manufacturing and controls information 

for gene therapy products, additional 

recommendations regarding the testing 

for replication competent retrovirus 

during the manufacture of retroviral 

vector-based gene therapy products and 

during the follow-up monitoring of 

patients who received retroviral vectorbased gene therapy products, and 

recommendations regarding the design 

of long-term follow-up observational 

studies for the collection of data on 

delayed adverse events following 

administration of a gene therapy 

product. Comments were requested on 

these draft guidances by October 10, 

2018. 

SIX DRAFT GUIDANCES PUBLISHED JULY 12, 2018 

Docket No. Draft guidance document title FR cite 

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.

83 FR 32309 

FDA–2008–D–0205 ........ Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New 

Drug Applications; Draft Guidance for Industry.

83 FR 32307 

FDA–2018–D–2173 ........ Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry.83 FR 32311 

FDA–2018–D–2236 ........ Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry ............................................. 83 FR 32302 

FDA–2018–D–2238 ........ Human Gene Therapy for Hemophilia; Draft Guidance for Industry ....................................................... 83 FR 32306 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45251 

SIX DRAFT GUIDANCES PUBLISHED JULY 12, 2018—Continued 

Docket No. Draft guidance document title FR cite 

FDA–2018–D–2258 ........ Human Gene Therapy for Rare Diseases; Draft Guidance for Industry ................................................. 83 FR 32303 

The Agency has received requests for 

a 60-day extension of the comment 

period for the six draft guidance 

documents. These requests conveyed 

concern that the current 90-day 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the draft 

guidance documents. 

FDA has considered these requests 

and is extending the comment period 

for the six draft guidance documents for 

60 days, until December 10, 2018. The 

Agency believes that a 60-day extension 

allows adequate time for interested 

persons to submit comments. 

II. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. 

1. Letter from Robert Falb, Director, U.S. 

Policy and Advocacy, Alliance for 

Regenerative Medicine, to Dr. Peter 

Marks, Director, Center for Biologics 

Evaluation and Research, FDA (July 23, 

2018). 

2. Letter from Sesquile Ramon, Ph.D., 

Director, Science and Regulatory Affairs, 

Biotechnology Innovation Organization, 

to FDA Dockets Management Staff 

(August 3, 2018). 

Dated: August 29, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19303 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0147] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry and Food and Drug 

Administration Staff; Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence for Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

FEDERAL REGISTER concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on ‘‘Guidance for 

Industry and Food and Drug 

Administration Staff; Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence for Tobacco Products.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 5, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 5, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 5, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2011–D–0147 for ‘‘Guidance for 

Industry and Food and Drug 

Administration Staff; Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence for Tobacco Products.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 


daltland on DSKBBV9HB2PROD with NOTICES