Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47531 

pharmacists) are not clearly 

communicated in REMS documents. 

Stakeholders have reported spending 

excessive time trying to locate, 

understand, and comply with REMS 

requirements. 

To address the stakeholders’ feedback, 

FDA is revising the 2009 draft guidance 

on the format and content of a REMS to 

include information to assist applicants 

in drafting clear, informative, and 

standardized REMS documents. This 

revised draft guidance provides updated 

recommendations on the format and 

content of a REMS document and 

supersedes the 2009 draft guidance. 

Additional and more detailed 

information is provided in the template 

appended to this guidance. 

The new format of the REMS 

document, as described in this revised 

draft guidance and appended template, 

contains substantially the same content 

as described in the 2009 draft guidance; 

however, the information has been 

reorganized. In the old format, the 

REMS requirements were organized by 

the elements described in the statute. In 

the new format, requirements are 

organized to describe who is responsible 

for implementing the requirement, 

when the requirement is to be 

implemented, what the required action 

is, and with what REMS material(s). 

Additionally, the new format supports 

submission of REMS documents in 

Structured Product Labeling (SPL) 

format. 

Certain information included in the 

2009 draft guidance has been revised 

and included in other guidances 

subsequently published and therefore 

has been omitted from this revised draft 

guidance. For example: 

• Information on how FDA 

determines when a REMS is necessary 

to ensure that the benefits of a drug 

outweigh its risks can be found in the 

draft guidance for industry, ‘‘FDA’s 

Application of Statutory Factors in 

Determining When a REMS Is 

Necessary’’ (at: https://www.fda.gov/

ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/

ucm521504.pdf). 

• Information on REMS modifications 

can be found in the guidance for 

industry, ‘‘Risk Evaluation and 

Mitigation Strategies: Modifications and 

Revisions’’ (at: https://www.fda.gov/

downloads/drugs/guidancecompliance

regulatoryinformation/guidances/

ucm441226.pdf). 

This revised guidance and appended 

template are being reissued in draft form 

to enable the public to review and 

comment before finalization. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The revised draft guidance, 

when finalized, will represent the 

current thinking of FDA on the format 

and content of a REMS document. 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. The Paperwork Reduction Act of 

1995 

This revised draft guidance contains 

information collection provisions that 

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 collection of 

information in the guidance was 

approved under OMB control numbers 

0910–0001 and 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: October 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22050 Filed 10–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5868] 

Requests for Reconsideration at the 

Division Level Under the Generic Drug 

User Fee Act; 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 

guidance for industry entitled ‘‘Requests 

for Reconsideration at the Division 

Level Under GDUFA.’’ This guidance 

provides recommendations for industry 

on the procedures for resolving 

scientific and/or regulatory issues or 

matters between FDA and applicants of 

abbreviated new drug applications 

(ANDAs) that wish to pursue a request 

for reconsideration within the review 

discipline at the division level or 

original signatory authority. This 

guidance also provides information for 

applicants to consider before pursuing a 

request for reconsideration, procedures 

for submitting a request for 

reconsideration, and the Agency’s 

process for responding to those requests. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 11, 2017 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– 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
47532 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 

1The FDA Reauthorization Act of 2017 (Pub. L. 

115–52) included the reauthorization of generic 

user fees as Title III, Generic Drug User 

Amendments of 2017 (GDUFA II). 

2017–D–5868 for ‘‘Requests for 

Reconsideration at the Division Level 

Under GDUFA; Draft Guidance for 

Industry; Availability.’’ 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 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Bercu, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1611, Silver Spring, 

MD 20993–0002, 240–402–6902. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Requests for Reconsideration at the 

Division Level Under GDUFA.’’ This 

guidance provides recommendations for 

industry on the procedures for resolving 

scientific and/or regulatory issues or 

matters between FDA and applicants of 

ANDAs that wish to pursue a request for 

reconsideration within the review 

discipline at the division level or 

original signatory authority. In 

accordance with ‘‘GDUFA 

Reauthorization Performance Goals and 

Program Enhancements Fiscal Years 

2018–2022’’ (GDUFA II Goals Letter or 

GDUFA II Commitment Letter; https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/GenericDrugUserFees/ 

UCM525234.pdf), FDA agreed to certain 

review goals and procedures for the 

review of requests for reconsideration 

received on or after October 1, 2017.1

As agreed to by FDA and industry in 

the GDUFA II Commitment Letter, 

applicants may pursue a request for 

reconsideration within the review 

discipline at the division level. In 

addition, if an applicant requests a 

teleconference as part of its request to 

reclassify a major amendment or 

standard review status, FDA will 

schedule and conduct the 

teleconference and decide 90 percent of 

such reclassification requests within 30 

days of the date of FDA’s receipt of the 

request for a teleconference. As stated in 

the GDUFA II Commitment Letter, this 

goal only applies when the applicant 

accepts the first scheduled 

teleconference date offered by FDA. 

This guidance provides additional 

details and recommendations 

concerning considerations for 

applicants before pursuing a request for 

reconsideration and procedures for 

submitting a request for reconsideration 

and the Agency’s process for responding 

to those requests. 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 ‘‘Requests for Reconsideration at the 

Division Level Under GDUFA.’’ 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 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3520), 

Federal Agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Applications for FDA Approval To 

Market a New Drug 

OMB Control Number 0910–0001— 

Revision 

The information collection request 

supports the Agency’s draft guidance 

entitled, ‘‘Requests for Reconsideration 

at the Division Level Under GDUFA.’’ 

As discussed in section I of this notice, 

this guidance provides information to 

respondents regarding procedures for 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47533 

submitting requests for reconsideration, 

including details on the content and 

format of the submission. Respondents 

to the collection of information are 

applicants of ANDAs. Based on 

available data with regard to similar 

information collections, FDA’s Center 

for Drug Evaluation and Research will 

receive approximately 150 requests for 

reconsideration annually from 75 

respondents. Because we estimate it will 

take 5 hours to prepare a request for 

reconsideration, we estimate it will take 

an average of 750 total hours annually 

for respondents to prepare and submit 

requests for reconsideration. The burden 

of the information collection, therefore, 

is estimated as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance recommendation Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Section IV: Procedures for Submitting and Responding to 

a Request for Reconsideration ........................................ 75 2 150 5 750 

1There are no capital or operating and maintenance costs associated with the collection of information. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or https://www.regulations

.gov. 

Dated: October 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22049 Filed 10–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0424] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Temporary 

Marketing Permit Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

13, 2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0133. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10–12M, 11601 Landsdown 

St., North Bethesda, MD 20852, 301– 

796–7729, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Temporary Marketing Permit 

Applications—21 CFR 130.17(c) and (i) 

OMB Control Number 0910–0133— 

Extension 

This information collection supports 

Agency regulations. Specifically, section 

401 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

341) directs FDA to issue regulations 

establishing definitions and standards of 

identity for food ‘‘whenever . . . such 

action will promote honesty and fair 

dealing in the interest of consumers 

. . . .’’ Under section 403(g) of the 

FD&C Act (21 U.S.C. 343(g)), a food that 

is subject to a definition and standard of 

identity prescribed by regulation is 

misbranded if it does not conform to 

such definition and standard of identity. 

Section 130.17 (21 CFR 130.17) provides 

for the issuance by FDA of temporary 

marketing permits that enable the food 

industry to test consumer acceptance 

and measure the technological and 

commercial feasibility in interstate 

commerce of experimental packs of food 

that deviate from applicable definitions 

and standards of identity. Section 

130.17(c) enables the Agency to monitor 

the manufacture, labeling, and 

distribution of experimental packs of 

food that deviate from applicable 

definitions and standards of identity. 

The information so obtained can be 

used in support of a petition to establish 

or amend the applicable definition or 

standard of identity to provide for the 

variations. Section 130.17(i) specifies 

the information that a firm must submit 

to FDA to obtain an extension of a 

temporary marketing permit. 

In the Federal Register of June 15, 

2017 (82 FR 27489), we published a 60- 

day notice requesting public comment 

on the proposed extension of this 

collection of information. No comments 

were received. 

We therefore estimate the burden of 

this collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

130.17(c)—Request for temporary marketing permit .......... 13 2 26 25 650 

130.17(i)—Request to extend marketing permit .................. 1 2 2 2 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 654 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES