30-Day Notice Manufactured Housing Survey

Federal Register / Vol. 84, No. 54 / Wednesday, March 20, 2019 / Notices

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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–
2018–D–1638 for ‘‘Pediatric HIV
Infection: Drug Product Development
for Treatment.’’ 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

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FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-32015-309-318/pdf/2015323389.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; 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:
Yodit Belew, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm., 6322, Silver Spring,
MD 20993–0002, 301–796–0705; 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 entitled
‘‘Pediatric HIV Infection: Drug Product
Development for Treatment.’’ The
purpose of this guidance is to provide
general recommendations on the
development of antiretroviral drug
products for the treatment of HIV
infection in pediatric patients. The
guidance addresses when to initiate
pediatric formulation development and
begin pediatric studies and offers
approaches for enrollment of subjects
into pediatric studies to help expedite
drug product development. This
guidance incorporates the comments
received for and finalizes the draft

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guidance of the same name issued on
May 14, 2018 (83 FR 22270). Changes
made to the draft guidance took into
consideration written and verbal
comments received. In addition to
editorial changes primarily for
clarification, the major changes are as
follows:
• Inclusion of a statement to address
neonates and
• Considerations on how to analyze
the adolescent data when adolescents
are included in the adult phase 3
clinical trials.
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 ‘‘Pediatric HIV
Infection: Drug Product Development
for Treatment.’’ 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 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 21 CFR part 312, 21
CFR part 314, and 21 CFR 201.56 and
201.57 have been approved under OMB
control numbers 0910–0014, 0910–0001,
and 0910–0572, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
Dated: March 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05232 Filed 3–19–19; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7011–N–08]

30-Day Notice of Proposed Information
Collection: Manufactured Housing
Survey
Office of the Chief Information
Officer, HUD.

AGENCY:

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ACTION:

Federal Register / Vol. 84, No. 54 / Wednesday, March 20, 2019 / Notices
Notice.

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

SUMMARY:

DATES:

Comments Due Date: April 19,

2019.
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
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
ADDRESSES:

Information Collection

Number of
respondents

A. Overview of Information Collection
Title of Information Collection:
Manufactured Housing Survey.
OMB Approval Number: 2528–0029.
Type of Request: Revision of a
currently approved collection.
Form Number: Form—C–MH–9A.
Description of the need for the
information and proposed use: The
Manufactured Housing Survey collects
data on the characteristics of newly
manufactured homes placed for
residential use. Key data collected
includes sales price and the number of
units placed and sold within 4 months
of shipment. Other selected housing
characteristics collected include size,
location, and titling. HUD uses the
statistics to respond to a Congressional
mandate in the Housing and
Community Development Act of 1980,
42 U.S.C. 5424 note, which requires
HUD to collect and report manufactured
home sales and price information for the
nation, census regions, states, and

Frequency of
response

Responses
per annum

Burden hour
per response

selected metropolitan areas and to
monitor whether new manufactured
homes are being placed on owned rather
than rented lots. HUD also used these
data to monitor total housing
production and its affordability.
Furthermore, the Manufactured
Housing Survey serves as the basis for
HUD’s mandated indexing of loan
limits. Section 2145 (b) of the Housing
and Economic Recovery Act (HERA) of
2008 requires HUD to develop a method
of indexing to annually adjust Title I
manufactured home loan limits. This
index is based on manufactured housing
price data collected by this survey.
Section 2145 of the HERA of 2008 also
amends the maximum loan limits for
manufactured home loans insured
under Title I. HUD implemented the
revised loan limits, as shown below, for
all manufactured home loans for which
applications are received on or after
March 3, 2009.
Method of Collection: The
methodology for collecting information
on new manufactured homes involves
contacting dealers from a monthly
sample of new manufactured homes
shipped by manufacturers. The units are
sampled from lists obtained from the
Institute for Building Technology and
Safety. Dealers that take shipment of the
selected homes are mailed a survey form
four months after shipment for
recording the status of the manufactured
home.
Annual
burden
hours

Hourly cost
per response

Annual cost

Manufactured Housing
Survey ......................

4,860

1

4,860

0.33

1,603.8

$0

$0

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

4,860

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

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

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

1,603.8

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

0

B. Solicitation of Public Comment

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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 Monday,
November 26, 2018 at 83 FR 60443.

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

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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.
Authority: Section 3507 of the Paperwork
Reduction Act of 1995, 44 U.S.C. Chapter 35.
Dated: March 6, 2019.
Anna P. Guido,
Department Reports Management Officer,
Office of the Chief Information Officer.
[FR Doc. 2019–05302 Filed 3–19–19; 8:45 am]
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DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7011–N–06]

30-Day Notice of Proposed Information
Collection: 2019 American Housing
Survey
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
information. The purpose of this notice

SUMMARY:

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