30 day-FRN

Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
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copies of the draft guidance to the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access to the draft guidance document.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:
Jeffrey Murray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6370,
Silver Spring, MD 20993–0002, 301–
796–1500.
SUPPLEMENTARY INFORMATION:

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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Smallpox (Variola Virus) Infection:
Developing Drugs for Treatment or
Prevention.’’ The purpose of this draft
guidance is to assist sponsors in all
phases of development of antiviral
drugs for the treatment or prevention of
smallpox (variola virus) infection. This
draft guidance addresses nonclinical
development, key study design
considerations for animal efficacy
studies to support potential new drug
application (NDA)/biologics license
application (BLA) submissions under
the animal rule (21 CFR part 314,
subpart I, for drugs and 21 CFR part 601,
subpart H, for biologics), and
considerations for obtaining a human
safety database.
This draft guidance revises the draft
guidance for industry entitled
‘‘Smallpox (Variola) Infection:
Developing Drugs for Treatment or
Prevention’’ issued on November 23,
2007 (72 FR 65750). The revisions
intend to streamline the guidance and
incorporate input from a public
workshop in 2009 and an advisory
committee meeting in 2011. This
revision contains the following changes:
• Modification and integration of
several sections to focus on
multidisciplinary considerations for
studies in animal models of
orthopoxvirus disease, including:
Æ Considerations for preliminary
assessments of antiviral activity in
animal models
Æ Key study design considerations for
animal efficacy studies to support
potential NDA/BLA submissions
under the animal rule
Æ Selection of an effective dose in
humans

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• Additional clarification on the
following:
Æ Key nonclinical virology issues
related to drug development under
the animal rule
Æ Key pharmacology/toxicology issues
Æ Considerations regarding healthy
volunteer safety trials, safety data
from non-smallpox clinical
experience, clinical trials in the event
of a public health emergency,
individual patient expanded access
investigational new drug applications
for emergency use, and emergency use
authorization
Æ Key clinical pharmacology issues that
may be affected by limitations in
collecting clinical data
Æ Key chemistry, manufacturing, and
controls issues, such as the
importance of developing
formulations for patients who are
unable to swallow solid oral dosage
formulations, as well as the
importance of generating stability data
needed to support a long expiration
dating period
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 developing drugs for the treatment
and prevention of smallpox (variola
virus) infection. 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 draft 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
collection of information in 21 CFR part
312 (investigational new drug
applications) has been approved under
OMB control number 0910–0014. The
collection of information in 21 CFR part
314 (NDAs) has been approved under
OMB control number 0910–0001. The
collection of information resulting from
special protocol assessments has been
approved under OMB control number
0910–0470. The collection of
information resulting from emergency
use authorization of medical products
has been approved under OMB control
number 0910–0595. The collection of
information resulting from individual
patient expanded access applications
has been approved under OMB control

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number 0910–0814. The collection of
information resulting from good
laboratory practices has been approved
under OMB control number 0910–0119.
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 or https://
www.regulations.gov.
Dated: July 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14749 Filed 7–10–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Cancellation;
Notice of Meeting
Notice is hereby given of the
cancellation of the National Cancer
Institute Special Emphasis Panel,
August 7, 2018, 10:00 a.m. to August 7,
2018, 5:00 p.m., National Cancer
Institute Shady Grove, 9609 Medical
Center Drive, 7W260, Rockville, MD
20850 which was published in the
Federal Register on June 8, 2018, 83 FR
26703.
This meeting has been cancelled due
to no proposal submissions.
Dated: July 5, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–14757 Filed 7–10–18; 8:45 am]
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DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7001–N–35]

30-Day Notice of Proposed Information
Collection: Production of Material or
Provision of Testimony by HUD in
Response to Demands in Legal
Proceedings Among Private Litigants
Office of the Chief Information
Officer, HUD.
ACTION: Notice.
AGENCY:

HUD is seeking approval from
the Office of Management and Budget
(OMB) for the information collection
described below. In accordance with the
Paperwork Reduction Act, HUD is
requesting comment from all interested
parties on the proposed collection of

SUMMARY:

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Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices

information. The purpose of this notice
is to allow for 30 days of public
comment.
DATES:

Comments Due Date: August 10,

2018.
Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control Number and should be sent to:
HUD Desk Officer, Office of
Management and Budget, New
Executive Office Building, Washington,
DC 20503; fax: 202–395–5806, Email:
OIRA [email protected]
FOR FURTHER INFORMATION CONTACT:
Anna P. Guido, Reports Management
Officer, QMAC, Department of Housing
and Urban Development, 451 7th Street
SW, Washington, DC 20410; email Anna
P. Guido at [email protected] or

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ADDRESSES:

Testimony by HUD in Response to
Demands in Legal Proceedings Among
Private Litigants.
OMB Approval Number: 2510–0014.
Type of Request: Revision of currently
approved collection.
Form Number: N/A.
Description of the need for the
information and proposed use: Section
15.203 of HUD’s regulations in 24 CFR
specify the manner in which demands
for documents and testimony from the
Department should be made. Providing
the information specified in 24 CFR
15.203 allows the Department to more
promptly identify documents and
testimony which a requestor may be
seeking and determine whether the
Department should produce such
documents and testimony.
Estimated Number of Respondents/
Estimated Number of Responses:

telephone 202–402–5535. This is not a
toll-free number. Person with hearing or
speech impairments may access this
number through TTY by calling the tollfree Federal Relay Service at (800) 877–
8339. Copies of available documents
submitted to OMB may be obtained
from Ms. Guido.
SUPPLEMENTARY INFORMATION: This
notice informs the public that HUD is
seeking approval from OMB for the
information collection described in
Section A.
The Federal Register notice that
solicited public comment on the
information collection for a period of 60
days was published on May 8, 2018 at
83 FR 20850.
A. Overview of Information Collection
Title of Information Collection:
Production of Material or Provision of

Information collection

Number of
respondents

Frequency of
response

Responses
per annum

Burden hour
per response

Annual burden
hours

Hourly cost
per response

Annual cost

§ 15.203 ........................

106.00

1.00

106.00

1.50

159.00

$49.56

$7,880.04

B. Solicitation of Public Comment

DEPARTMENT OF THE INTERIOR

This notice is soliciting comments
from members of the public and affected
parties concerning the collection of
information described in Section A on
the following:
(1) Whether the proposed collection
of information is necessary for the
proper performance of the functions of
the agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information;
(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 those
who are to respond; including through
the use of appropriate automated
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
HUD encourages interested parties to
submit comment in response to these
questions.

Fish and Wildlife Service

Authority: Section 3507 of the Paperwork
Reduction Act of 1995, 44 U.S.C. Chapter 35.
Dated: June 25, 2018.
Anna P. Guido,
Department Reports Management Officer,
Office of the Chief Information Officer.
[FR Doc. 2018–14839 Filed 7–10–18; 8:45 am]
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[FWS–R3–R–2018–N064; FF09R50000 18X
FVRS84510900000; OMB Control Number
1018–New]

Agency Information Collection
Activities; Pre-Acquisition Tracking
System
Fish and Wildlife Service,
Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, we,
the U.S. Fish and Wildlife Service
(Service, we) are proposing a new
information collection.
DATES: Interested persons are invited to
submit comments on or before
September 10, 2018.
ADDRESSES: Send your comments on the
information collection request (ICR) by
mail to the Service Information
Collection Clearance Officer, U.S. Fish
and Wildlife Service, MS: BPHC, 5275
Leesburg Pike, Falls Church, VA 22041–
3803 (mail); or by email to Info_Coll@
fws.gov. Please reference OMB Control
Number 1018–PATS in the subject line
of your comments.
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact Madonna L. Baucum,
Service Information Collection
Clearance Officer, by email at Info_
SUMMARY:

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[email protected], or by telephone at (703)
358–2503.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995, we provide the
general public and other Federal
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
We are soliciting comments on the
proposed ICR that is described below.
We are especially interested in public
comment addressing the following
issues: (1) Is the collection necessary to
the proper functions of the Service; (2)
will this information be processed and
used in a timely manner; (3) is the
estimate of burden accurate; (4) how
might the Service enhance the quality,
utility, and clarity of the information to
be collected; and (5) how might the
Service minimize the burden of this
collection on the respondents, including
through the use of information
technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal

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