51418 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 

By Order of the Federal Maritime 

Commission. 

Dated: November 1, 2017. 

JoAnne D. O’ Bryant, 

Program Analyst. 

[FR Doc. 2017–24119 Filed 11–3–17; 8:45 am] 

BILLING CODE 6731–AA–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Numbers: 93.581, 93.587, 93.612] 

Notice of Final Issuance Adopting 

Administration for Native Americans 

Program Policies and Procedures 

AGENCY: Administration for Native 

Americans, ACF, HHS. 

ACTION: Issuance of final policies. 

SUMMARY: Administration for Native 

Americans (ANA) is issuing final 

interpretive rules, general statements of 

policy and rules of agency organization, 

procedure, or practice relating to the 

following six proposed FY2018 Funding 

Opportunity Announcements (FOAs): 

Environmental Regulatory Enhancement 

(HHS–2018–ACF–ANA–NR–1344); 

Native American Language Preservation 

and Maintenance—Esther Martinez 

Immersion (HHS–2018–ACF–ANA–NB– 

1343); Native American Language 

Preservation and Maintenance (HHS– 

2018–ACF–NA–NL–1342); Social and 

Economic Development Strategies 

(HHS–2018–ACF–ANA–NA–1339); 

Social and Economic Development 

Strategies—Alaska (HHS–2018–ACF– 

ANA–NK–1340); and Native Youth 

Initiative for Leadership, Empowerment, 

and Development (HHS–2018–ACF– 

ANA–NC–1341). 

DATES: The policies described in the 

Notice for Public Comment (NOPC), as 

amended in this notice if applicable, are 

effective immediately upon publication 

of this notice. 

FOR FURTHER INFORMATION CONTACT: 

Carmelia Strickland, Director, Division 

of Program Operations, Administration 

for Native Americans, (877) 922–9262, 

ANAComments@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

814 of the Native American Programs 

Act of 1974 (NAPA), as amended, 

requires ANA to provide notice and 

allow for comment on its proposed 

interpretive rules and general 

statements of policy. On August 14, 

2017, ANA published a NOPC with 

proposed policy and program 

clarifications for the FY 2018 FOAs. 

ANA also follows the ACF Tribal 

Consultation Policy, and sent a Dear 

Tribal Leader letter informing tribes of 

the NOPC and made them aware of the 

September 15 deadline for comment 

submission. This Notice responds to 

comments regarding ANA’s August 14, 

2017, NOPC (82 FR 37861) and the 

tribal consultation afforded through the 

Dear Tribal Leader letter issued August 

14, 2017. In addition, this notification 

includes a clarification in a new 

administrative policy, a modification to 

the project start date for Native 

Language programs, and a notification 

regarding the application period for FY 

2018 FOAs. 

A. Comments and Responses to the 

August 14, 2017, NOPC 

ANA published a NOPC in the 

Federal Register on August 14, 2017, 

with proposed policy and program 

clarifications, modifications, and 

activities for the FY 2018 FOAs. ANA 

sent a Dear Tribal Leader letter 

electronically and via U.S. mail the 

same day with the NOPC attached. The 

NOPC provided proposed clarifications, 

modifications, and new text for six 

proposed FY 2018 FOAs. The FY 2018 

FOAs are based on the FY 2017 FOAs, 

previously published as: Environmental 

Regulatory Enhancement (HHS–2017– 

ACF–ANA–NR–1221); Native American 

Language Preservation and 

Maintenance—Esther Martinez 

Immersion (HHS–2017–ACF–ANA–NB– 

1226); Native American Language 

Preservation and Maintenance (HHS– 

2017–ACF–ANA–NL–1235); Social and 

Economic Development Strategies 

(HHS–2017–ACF–ANA–NA–1236); 

Social and Economic Development 

Strategies—Alaska (HHS–2015–ACF– 

ANA–NK– 0960); and Native Youth 

Initiative for Leadership, Empowerment, 

and Development (HHS–2017–ACF– 

ANA–NC–1263). The public comment 

period was open for 30 days. ANA also 

publicized a background call on the 

NOPC for August 23, 2017, and had 14 

callers on the line. 

ANA did not receive any feedback on 

the FOA changes from tribal 

governments. ANA received one 

response to the NOPC from the SissetonWahpeton Oyate Dakotah Language 

Institute. Comments expressed concerns 

or made suggestions about some of the 

changes. ANA considered the comments 

and determined there to be none that 

required changes to any of the FOAs. 

The following includes comments from 

the Sisseton-Wahpeton Oyate Dakotah 

Language Institute and responses 

provided by ANA: 

Comment: 

When changing the application criteria, 

please make the changes effective two grant 

cycles from the adoption date. Sometimes the 

application due dates are changed because 

there are upcoming changes to the Funding 

Opportunity Announcement and a comment 

period has to be allowed. And then, the grant 

start dates are pushed back and then the 

entire timeline developed in the project 

planning is no longer applicable. 

Response: The FOAs, which contain 

the application criteria specific to each 

program area, are published on an 

annual basis. Through the NOPC, ANA 

provided advance notice to applicants 

about the proposed changes in FY 2018 

to its six FOAs. ANA is unable to 

provide specific language until the 

publication of the actual FOAs. 

Therefore, ANA is not able to make 

changes to the application criteria prior 

to the effective date. 

Comment: Regarding the Paperwork 

Reduction Act (PRA) Notice 

inaccurately reflecting the amount of 

time it takes to file an ANA application: 

Each hour spent on a grant application is 

one less hour that can be spent working on 

our endangered language, especially for a 

small program like ours. A more accurate 

Paperwork Reduction Notice may have 

weight in deciding whether it is actually 

worth it to invest the amount of time it takes 

to complete the process with very little 

chance of success. 

Response: ANA’s FOAs are drafted 

within the context of a Uniform Project 

Description (UPD), which serves to 

provide the overall structure for all 

applications submitted to the 

Administration for Children and 

Families (ACF). The UPD includes 

specific standard text that applies to all 

ACF programs, in combination with 

program-specific text that is added by 

individual program offices. The PRA 

notice is part of the ACF UPD, which is 

managed ACF-wide, and determined 

based on the average amount of time it 

takes to complete the project description 

and the budget and budget justification 

for ACF programs as a whole. The 

estimated burden of 60 hours does not 

include supplementary information that 

an applicant may want to include. 

While there is likely to be variation 

among different programs and 

applicants, the average estimated time 

to complete an application for ACF 

programs is 60 hours. ANA will forward 

the comment to the ACF branch that 

handles the UPD to be considered upon 

the renewal of the PRA clearance for the 

UPD. 

Comment: 

If you are putting in new terms that are 

common terms to those working in a federal 

program accepting grant applications, please 

make sure the new terms are adequately 

explained. How can a person comment about 

changing from ‘‘results’’ and ‘‘benefits’’ to 


Pmangrum on DSK3GDR082PROD with NOTICES
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] 

BILLING CODE 4184–34–P 

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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