30 Day FRN

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Federal Register / Vol. 84, No. 95 / Thursday, May 16, 2019 / Notices

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 guidances 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access to the draft guidance documents.
FOR FURTHER INFORMATION CONTACT:

Wendy Good, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714,
Silver Spring, MD 20993–0002, 240–
402–1146.
SUPPLEMENTARY INFORMATION:

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I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
As described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific guidances and provide a
meaningful opportunity for the public to
consider and comment on those
guidances. Under that process, draft
guidances are posted on FDA’s website
and announced periodically in the
Federal Register. The public is
encouraged to submit comments on
those recommendations within 60 days
of their announcement in the Federal
Register. FDA considers any comments
received and either publishes final
guidances or publishes revised draft
guidances for comment. Guidances were
last announced in the Federal Register
on February 25, 2019 (84 FR 6005). This
notice announces draft product-specific
guidances, either new or revised, that
are posted on FDA’s website.

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II. Drug Products For Which New Draft
Product-Specific Guidances Are
Available

to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
FDA is announcing the availability of guidance practices regulation (21 CFR
new draft product-specific guidances for 10.115). These draft guidances, when
industry for drug products containing
finalized, will represent the current
the following active ingredients:
thinking of FDA on, among other things,
the product-specific design of BE
TABLE 1—NEW DRAFT PRODUCT-SPE- studies to support ANDAs. They do not
CIFIC GUIDANCES FOR DRUG PROD- establish any rights for any person and
UCTS
are not binding on FDA or the public.
You can use an alternative approach if
Acetaminophen; Codeine phosphate
it satisfies the requirements of the
Apalutamide
applicable statutes and regulations.
Beclomethasone dipropionate
These guidances are not subject to
Benoxinate hydrochloride; Fluorescein soExecutive Order 12866.
dium
Bictegravir sodium; Emtricitabine; Tenofovir
alafenamide fumarate
Brimonidine tartrate
Budesonide
Chlorpheniramine
maleate;
Ibuprofen;
Pseudoephedrine hydrochloride
Cyclosporine
Desloratadine; Pseudoephedrine sulfate
Desmopressin acetate
Efavirenz; Lamivudine; Tenofovir disoproxil
fumarate (multiple Reference Listed Drugs)
Eravacycline dihydrochloride
Estradiol; levonorgestrel
Fluticasone furoate
Fluticasone propionate
Fluticasone propionate; Salmeterol xinafoate
Fosnetupitant
chloride
hydrochloride;
Palonosetron hydrochloride
Halcinonide
Lamivudine; Tenofovir disoproxil fumarate
Naproxen
Omeprazole magnesium
Primidone
Timolol maleate
Tobramycin

III. Drug Products for Which Revised
Draft Product-Specific Guidances are
Available
FDA is announcing the availability of
revised draft product-specific guidances
for industry for drug products
containing the following active
ingredients:

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Azelaic acid (multiple Reference
Drugs)
Betaxolol hydrochloride
Brimonidine tartrate; Brinzolamide
Brinzolamide
Fosfomycin tromethamine
Ivermectin
Methylprednisolone
Prednisolone acetate
Tofacitinib citrate

Listed

For a complete history of previously
published Federal Register notices
related to product-specific guidances, go

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IV. Electronic Access
Persons with access to the internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: May 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10165 Filed 5–15–19; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0458
Revision]

Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
revision of a collection for public
comment.

SUMMARY:

Comments on the ICR must be
received on or before June 17, 2019.
ADDRESSES: Submit your comments to
[email protected] or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, [email protected]
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
OS–0990–0458 Revision, and project
title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
DATES:

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22133

Federal Register / Vol. 84, No. 95 / Thursday, May 16, 2019 / Notices
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Domestic
Violence Housing First Demonstration
Evaluation.
Type of Collection: Revision.
OMB No.: 0990–0458.
Abstract: The Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) within the U.S. Department of
Health and Human Services, in
partnership with the Office for Victims
of Crimes within the U.S. Department of
Justice, is seeking approval by OMB for

a revision to add a 24-month follow-up
data collection to an existing
information collection request entitled,
‘‘Domestic Violence Housing First
(DVHF) Demonstration Evaluation’’
(OMB Control Number: HHS–OS–0990–
0458). The Washington State Coalition
against Domestic Violence (WSCADV) is
overseeing and coordinating an
evaluation of the DVHF Demonstration
project through a contract with ASPE.
This quasi-experimental research study
involves longitudinally examining the
program effects of DVHF on domestic
violence survivors’ safety and housing
stability. The findings will be of interest
to the general public, to policy-makers,
and to organizations working with
domestic violence survivors.
Current data collection that has been
approved by OMB includes in-depth,
private interviews with 320 domestic
violence survivors conducted by trained
professional staff. The data are currently
approved for collection at study

enrollment (Time 1), and at follow-up
interviews every six months after the
Time 1 Interview (i.e., 6, 12, and 18
months) to examine the match between
needs and services, as well as their
safety and housing stability. The
proposed revision to the collection
would add a fourth follow-up data
collection to be administered 24 months
after study enrollment (Time 1) to
examine longer-term impacts of the
Domestic Violence Housing First
Demonstration program. The follow-up
survey is identical to the one used at the
6, 12, and 18 month follow-up. The
respondents are domestic violence
survivors who are enrolled in the
Domestic Violence Housing First
Demonstration Evaluation (OMB
Control Number HHS–OS–0990–0458).
Study enrollment is taking place over 15
months, so the annualized burden for
the 24-month follow-up survey is based
on 12/15 (256) of the expected sample
(320).

ANNUALIZED BURDEN HOUR TABLE
Number of
responses per
respondent

Average
burden hours
per response

Type of
respondent

Follow-up Interview ...........................

Domestic violence survivors ............

256

1

1.25

320

Total ...........................................

..........................................................

........................

........................

........................

320

Dated: May 8, 2019.
Terry Clark,
Office of the Secretary, Asst. Paperwork
Reduction Act Reports Clearance Officer.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

agreements for American Indians into
Psychology. This program is authorized
under section 217 of the Indian Health
Care Improvement Act, Public Law 94–
437, as amended (IHCIA), codified at 25
U.S.C. 1621p. This program is described
in the Assistance Listings located at
https://beta.sam.gov (formerly known as
Catalog of Federal Domestic Assistance)
under 93.970.

Indian Health Service

Background

[FR Doc. 2019–10107 Filed 5–15–19; 8:45 am]
BILLING CODE 4150–05–P

American Indians Into Psychology
Announcement Type: New and
Competing Continuation.
Funding Announcement Number:
HHS–2019–IHS–INPSY–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance) Number: 93.970.

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Annual
number of
respondents

Form name

Key Dates
Application Deadline Date: June 20,
2019.
Earliest Anticipated Start Date: July
20, 2019.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS)
Division of Health Professions Support,
is accepting applications for cooperative

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The IHS, an agency within the
Department of Health and Human
Services (HHS), is responsible for
providing Federal health services to
American Indians and Alaska Natives
(AI/AN). The mission of the IHS is to
raise the physical, mental, social, and
spiritual health of AI/AN. The IHCIA
authorizes the IHS to administer
programs that are designed to attract
and recruit qualified individuals into
health professions to ensure the
availability of health professionals to
serve AI/AN populations. Section 217 of
the IHCIA authorizes IHS to administer
the American Indians into Psychology
Program. Within the Section 217
program, IHS provides grants to colleges
and universities to develop and
maintain psychology education

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Total annual
burden hours

programs and recruit individuals to
become Clinical Psychologists who will
provide services to AI/AN people.
Psychology program scholarship grants
may be used by the educational
institution to provide scholarships to
Indian students enrolled in clinical
psychology education programs.
According to the terms and conditions
of the psychology program scholarship
grant award, scholarship awards are for
a l-year period; additional scholarship
support may be awarded to each eligible
student for up to four years (maximum).
Purpose
The purpose of this IHS cooperative
agreement is to augment the number of
Indian Clinical Psychologists who
deliver health care services to AI/AN
communities. The primary objectives of
this cooperative agreement award are to:
(1) Recruit and train individuals to be
Clinical Psychologists; and (2) provide
scholarships to individuals enrolled in
schools of clinical psychology to pay
tuition, books, fees and stipends for
living expenses.
II. Award Information
Funding Instrument
Cooperative Agreement.

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