Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51419 

‘‘outcomes’’ and ‘‘outputs’’ if I don’t know 

what they mean to you? Or are they the same 

meaning to you and it’s just a change in the 

words that are going to be used? 

Response: ANA’s intent is to provide 

more universally accepted terminology, 

especially for evaluation requirements 

and criteria. Definitions and examples 

of all new terms will be provided in 

each of the FY 2018 FOAs. Any new 

terminology will be addressed in 

Section I. Program Description of the 

FOA. ANA will explain each term and 

include examples of each. Definitions 

will be included in the appendix of each 

FOA. 

B. ANA Administrative Policy 

Regarding Prioritized Funding for 

Local, Community-Based, Native 

American Organizations as Described 

in the August 14, 2017, NOPC (82 FR 

37861) 

ANA has edited the description of 

this policy since it was published in the 

Federal Register, to further clarify the 

requirements for non-local, national, 

and regional organizations. If approved, 

ANA intends to include this policy in 

all FY 2018 FOAs as stated below: 

Prioritized Funding for Communitybased Native American Organizations: 

ANA reserves the right to prioritize 

funding to community-based Native 

American organizations serving their local 

communities and populations. Applications 

from non-local, national, and regional 

organizations that propose projects to serve 

multiple communities, or to be performed in 

a different geographic location, must clearly 

demonstrate that the need for the project was 

originated by the each community being 

served, and that the community and/or tribal 

government supports the proposed project. 

They must also describe how each 

community was selected, identify and 

describe the intended beneficiaries, 

demonstrate community involvement in the 

development of the project, and discuss a 

community-based delivery strategy for the 

project. The proposed project goals, 

objectives, and outcomes must address goals 

of the community being served. National and 

regional organizations must describe their 

membership, and define how the 

organization operates. The type of 

community to be served will determine the 

type of documentation necessary to support 

the project. 

C. Additional Information Regarding 

Project Start Dates for Language 

Preservation and Maintenance, and 

Native Language Esther Martinez 

Immersion Grants 

Through continued discussions with 

ANA grantees and stakeholders, ANA 

has determined that moving the start 

date from August 1 to July 1 for projects 

funded under the Native Language 

Preservation and Maintenance and the 

Native Language Esther Martinez 

Immersion programs will align reporting 

requirements to reduce the number of 

required federal financial reports, 

thereby reducing the reporting burden 

for grantees. In addition, an earlier start 

date will provide projects with 

additional time for planning and start 

up prior to the start of the school year, 

which marks the beginning of 

instruction for many Native Language 

projects. Therefore, ANA intends to 

implement a July 1 start date for all 

projects funded under the Native 

Language Preservation and Maintenance 

and Native Language Esther Martinez 

Immersion FOAs for FY 2018. 

D. Application Period Notification 

ANA would like to notify potential 

applicants that the open application 

period to respond to FOAs has been 

updated to a minimum of 60 days to 

support the timely award of new grants. 

E. Funding Opportunity 

Announcements 

For information on the types of 

projects funded by ANA, please refer to 

ANA’s Web site for information on our 

program areas and FOAs: https://

www.acf.hhs.gov/programs/ana. Prepublication information on ANA’s FOAs 

will be available at https://

www.grants.gov/web/grants/searchgrants.html by clicking on ‘Forecasted’’ 

under Opportunity Status and 

‘‘Administration for Children and 

Families—ANA [HHS–ACF–ANA]’’ on 

the left side of the page. Synopses and 

application forms will be available on 

www.Grants.gov. 

Stacey Ecoffey, 

Acting Commissioner, Administration for 

Native American, ACF, Acting Deputy 

Assistant Secretary for Native American 

Affairs, Department of Health and Human 

Services. 

[FR Doc. 2017–24124 Filed 11–3–17; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0221] 

Formal Dispute Resolution: Sponsor 

Appeals Above the Division Level; 

Guidance for Industry and Review 

Staff; 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 

guidance for industry and review staff 

entitled ‘‘Formal Dispute Resolution: 

Sponsor Appeals Above the Division 

Level.’’ This guidance provides 

recommendations for industry and 

review staff on the procedures in the 

Center for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER) for 

resolving scientific and/or medical 

disputes between CDER or CBER and 

sponsors that cannot be resolved at the 

division level. This guidance describes 

the formal dispute resolution 

procedures for sponsors that wish to 

appeal a scientific and/or medical issue 

to the office or center level and provides 

a structured process for resolving 

disputes. This guidance finalizes the 

revised draft guidance entitled ‘‘Formal 

Dispute Resolution: Appeals Above the 

Division Level’’ issued September 9, 

2015, and replaces the guidance of the 

same name issued February 2000. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 6, 2017. 

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: 


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51420 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 

• 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– 

2013–D–0221 for ‘‘Formal Dispute 

Resolution: Sponsor Appeals Above the 

Division Level; Guidance for Industry 

and Review Staff; 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 CDR 

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, or the Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

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 that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Khushboo Sharma, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6486, 

Silver Spring, MD 20993–0002, 301– 

796–0700; or, Stephen Ripley, 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 guidance for industry and review staff 

entitled ‘‘Formal Dispute Resolution: 

Sponsor Appeals Above the Division 

Level.’’ During the course of review of 

an investigational new drug application, 

new drug application, biologics license 

application, or abbreviated new drug 

application, a wide variety of important 

scientific and/or medical issues are 

considered that are central to product 

development. Sometimes, a sponsor 

may disagree with the Agency on a 

matter, and a dispute arises. Because 

these disputes often involve complex 

scientific and/or medical matters, it is 

critical to have procedures in place to 

help ensure open and prompt 

discussion. The procedures and policies 

described in this guidance are intended 

to promote rapid and fair resolution of 

scientific and/or medical disputes 

between a sponsor and CDER or CBER. 

This guidance finalizes the revised 

draft guidance entitled ‘‘Formal Dispute 

Resolution: Appeals Above the Division 

Level’’ issued September 9, 2015, and 

replaces the guidance of the same name 

issued February 2000. Based on the 

docket comments for the revised draft 

guidance, FDA made clarifications to 

this guidance. The guidance was also 

clarified to reflect that it describes the 

formal dispute resolution procedures 

only for sponsors that wish to appeal a 

scientific and/or medical issue 

regarding their applications regulated by 

CDER or CBER and does not apply to 

other individuals or entities. In 

addition, the guidance was updated to 

reflect the changes under the 2017 

reauthorization of the Generic Drug User 

Fee Amendments of 2012 (GDUFA) 

regarding timelines for reviewing 

disputes involving drug applications 

covered by GDUFA. 

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 formal dispute 

resolution requests for appeals above 

the division level. 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 guidance refers to previously 

approved collections of information 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 collections 

of information in this guidance have 

been approved under OMB control 

number 0910–0430. This guidance 

finalizes a revision of an earlier version 

of the guidance. This version contains 

no additional information collections; 

therefore, it continues to be covered 

under OMB control number 0910–0430. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/

guidancecompliance

regulatoryinformation/guidances/ 

default.htm, https://www.fda.gov/

biologicsbloodvaccines/

guidancecompliance

regulatoryinformation/default.htm, or 

https://www.regulations.gov. 

Dated: October 31, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24096 Filed 11–3–17; 8:45 am] 

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