Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices 31399 

of authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegations, provided they are 

consistent with this reorganization. 

II. Electronic Access. Persons 

interested in seeing the completed Staff 

Manual Guide can find it on FDA’s 

Webs site at: http://www.fda.gov/ 

AboutFDA/ReportsManualsForms/ 

StaffManualGuides/default.htm. 

(Authority: 44 U.S.C. § 3101.) 

Dated: June 28, 2018. 

Alex M. Azar II, 

Secretary. 

[FR Doc. 2018–14375 Filed 7–3–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5670] 

Abbreviated New Drug Application 

Submissions—Amendments to 

Abbreviated New Drug Applications 

Under the Generic Drug User Fee Act; 

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 final 

guidance for industry entitled ‘‘ANDA 

Submissions—Amendments to 

Abbreviated New Drug Applications 

Under GDUFA.’’ This guidance finalizes 

the October 2017 draft guidance for 

industry ‘‘ANDA Submissions— 

Amendments to Abbreviated New Drug 

Applications Under GDUFA.’’ This 

guidance is intended to explain to 

applicants how the review goals 

established as part of the Generic Drug 

User Fee Amendments Reauthorization 

of 2017 (GDUFA II) apply to 

amendments to either abbreviated new 

drug applications (ANDAs) or prior 

approval supplements (PASs) submitted 

to FDA under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). This 

guidance describes amendment 

classifications and categories and 

explains how amendment submissions 

may affect an application’s review goal 

dates. The guidance also describes how 

FDA will review amendments submitted 

to ANDAs and PASs received prior to 

October 1, 2017, the effective date to 

implement the GDUFA II review goals. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 5, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2017–D–5670 for ‘‘ANDA 

Submissions—Amendments to 

Abbreviated New Drug Applications 

Under GDUFA.’’ 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 this 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Giaquinto Friedman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1670, 

Silver Spring, MD 20993–0002, 240– 


amozie on DSK3GDR082PROD with NOTICES1
31400 Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices 

402–7930, elizabeth.giaquinto@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘ANDA 

Submissions—Amendments to 

Abbreviated New Drug Applications 

Under GDUFA.’’ This guidance finalizes 

the October 2017 draft guidance for 

industry ‘‘ANDA Submissions— 

Amendments to Abbreviated New Drug 

Applications Under GDUFA.’’ This 

guidance is intended to assist applicants 

preparing to submit amendments to 

ANDAs or to PASs to FDA under 

section 505(j) of the FD&C Act (21 

U.S.C. 355(j)) by explaining how the 

review goals established as part of 

GDUFA II apply to these submissions. 

In accordance with the GDUFA 

Reauthorization Performance Goals and 

Program Enhancements Fiscal Years 

2018–2022 (GDUFA II Commitment 

Letter: https://www.fda.gov/downloads/

ForIndustry/UserFees/GenericDrug

UserFees/ucm525234.pdf), FDA agreed 

to certain review goals and procedures 

for the review of amendments pending 

as of or received on or after the GDUFA 

II effective date. 

The GDUFA II Commitment Letter 

reflects significant changes in the 

classification of and review goals for 

amendments to ANDAs and PASs under 

the Generic Drug User Fee Amendments 

of 2012 (GDUFA I). Under GDUFA I, 

amendments were classified into a 

complex Tier system based on the 

following factors: (1) Whether the 

amendment was solicited (submitted in 

response to a complete response letter) 

or unsolicited (submitted on the 

applicant’s own initiative); (2) whether 

the amendment was major or minor; the 

number of amendments submitted to the 

ANDA or PAS; and (3) whether an 

inspection was necessary to support the 

information contained in the 

amendment. 

GDUFA II simplified the amendment 

review goals and no longer subjects 

them to a Tier system; however, review 

goals are still dependent on several 

factors. In general, under GDUFA II, 

amendments will be designated as 

either standard or priority; will be 

classified as major or minor, and will 

receive a goal date based on the factors 

discussed in the draft guidance, 

including whether a preapproval 

inspection is needed. This guidance 

supersedes the December 2001 guidance 

for industry ‘‘Major, Minor, and 

Telephone Amendments to Abbreviated 

New Drug Applications’’ and the July 

2014 draft guidance for industry 

‘‘ANDA Submissions—Amendments 

and Easily Correctable Deficiencies 

Under GDUFA,’’ both of which will be 

withdrawn. This guidance finalizes the 

October 2017 draft guidance for 

industry ‘‘ANDA Submissions— 

Amendments to Abbreviated New Drug 

Applications Under GDUFA.’’ The final 

guidance contains clarifications to the 

draft guidance of the same title that 

published in October 2017. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘ANDA 

Submissions—Amendments to 

Abbreviated New Drug Applications 

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 

This 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 314.96 have been approved 

under OMB control number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or https://

www.regulations.gov. 

Dated: June 29, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14429 Filed 7–3–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Advisory Council on Alzheimer’s 

Research, Care, and Services; Meeting 

AGENCY: Assistant Secretary for 

Planning and Evaluation, HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

public meeting of the Advisory Council 

on Alzheimer’s Research, Care, and 

Services (Advisory Council). The 

Advisory Council on Alzheimer’s 

Research, Care, and Services provides 

advice on how to prevent or reduce the 

burden of Alzheimer’s disease and 

related dementias on people with the 

disease and their caregivers. The 

Advisory Council will spend the 

majority of the July meeting considering 

recommendations made by each of the 

three subcommittees to present to the 

Secretary of HHS and Congress. 

Additional presentations in the 

afternoon will include a presentation on 

a recent study by RAND on the health 

care infrastructure, the CDC/ 

Alzheimer’s Association’s joint Healthy 

Brain Initiative Roadmap, federal 

workgroup updates, and updates on 

work by the non-federal members. 

DATES: The meeting will be held on July 

30, 2018 from 9:00 a.m. to 5:00 p.m. 

EDT. 

ADDRESSES: The meeting will be held in 

Room 800 in the Hubert H. Humphrey 

Building, 200 Independence Avenue 

SW, Washington, DC 20201. 

Comments: Time is allocated in the 

afternoon on the agenda to hear public 

comments. The time for oral comments 

will be limited to two (2) minutes per 

individual. In lieu of oral comments, 

formal written comments may be 

submitted for the record to Rohini 

Khillan, OASPE, 200 Independence 

Avenue SW, Room 424E, Washington, 

DC 20201. Comments may also be sent 

to napa@hhs.gov. Those submitting 

written comments should identify 

themselves and any relevant 

organizational affiliations. Those 

intending to make public comments at 

the meeting must submit their 

comments either by mail or email ahead 

of time for the record. Comments are 

due no later than Monday, July 23, 

2018. 

FOR FURTHER INFORMATION CONTACT: 

Rohini Khillan (202) 690–5932, 

rohini.khillan@hhs.gov. Note: Seating 

may be limited. Those wishing to attend 

the meeting must send an email to 

napa@hhs.gov and put ‘‘July 30 Meeting 

Attendance’’ in the Subject line by 

Friday, July 20, so that their names may 

be put on a list of expected attendees 

and forwarded to the security officers at 

the Department of Health and Human 

Services. Any interested member of the 

public who is a non-U.S. citizen should 

include this information at the time of 

registration to ensure that the 

appropriate security procedure to gain 

entry to the building is carried out. 

Although the meeting is open to the 

public, procedures governing security 

and the entrance to Federal buildings 

may change without notice. If you wish 

to make a public comment, you must 

note that within your email. 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 


amozie on DSK3GDR082PROD with NOTICES1