Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 8278-8279 [2018-03849]
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8278
Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices
DCH-Performance Monitoring Database
(DCH–PMD). Forty-four previously
funded Partnership to Improve
Community Health awardees will no
longer be included in this collection due
to funding cessation.
The information system collects
information to enable the accurate,
reliable, uniform and timely submission
to CDC of each awardee’s work plan and
progress reports. Monitoring allows CDC
to: (1) Determine whether an awardee is
meeting performance goals; (2) make
adjustments in the type and level of
technical assistance provided to
awardees; and (3) provide oversight of
the use of federal funds.
CDC also requests OMB approval to
conduct targeted, special purpose
information collections on an as-needed
basis. Due to substantial interest in the
REACH program from a variety of
stakeholders, CDC estimates that each
REACH awardee may receive an
invitation to participate in one special
purpose information collection.
Methods for these data collections could
include telephone interviews, in-person
interviews, Web-based surveys, or
paper-and-pencil surveys. CDC will
submit each special-purpose
information collection request to OMB
for approval through the Change
Request mechanism, and will include
the data collection instrument(s) and a
description of purpose and methods.
CDC seeks approval for one year to
collect the necessary data. Also, CDC
requires cooperative agreement awardee
semi-annual progress reporting
participation, but voluntary for some
special-purpose data collections.
There are no costs to respondents
other than their time. CDC estimates no
change to the average burden per
response for routine, semi-annual
reporting (estimated at three hours). The
total estimated annualized burden hours
for an additional year of information
collection are 588.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
DCH Program Awardees (state, local and
tribal government sector).
DCH Program Awardees (private sector) .......
DCH MIS: Semi-annual reporting ..................
Special Data Request ....................................
DCH MIS: Semi-annual reporting ..................
Special Data Request ....................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–03803 Filed 2–23–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–1119; FDA–
2010–N–0622; FDA–2011–N–0019; FDA–
2010–N–0594; FDA–2011–N–0016; FDA–
2009–N–0501; FDA–2014–N–0222; FDA–
2017–D–0040; and FDA–2016–N–3585]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
Average
burden per
response
(in hours)
Number of
responses per
respondent
18
18
31
31
2
1
2
1
3
6
3
6
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
daltland on DSKBBV9HB2PROD with NOTICES
Title of collection
OMB control No.
Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods ............................................................................................................
Color Additive Certification Requests and Recordkeeping .........................................................................
Customer/Partner Service Surveys .............................................................................................................
Focus Groups as Used by the Food and Drug Administration ...................................................................
Recordkeeping and Records Access Requirements for Food Facilities .....................................................
Reporting and Recordkeeping Requirements for Reportable Food ............................................................
Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products ...........................................................................................................................................................
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0910–0560
0910–0643
0910–0693
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Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices
8279
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
Title of collection
OMB control No.
Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD) ..........................
Character-Space-Limited Online Prescription Drug Communications ........................................................
Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Agency guidances at any time as
follows:
[FR Doc. 2018–03849 Filed 2–23–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0436]
Q11 Development and Manufacture of
Drug Substances—Questions and
Answers (Chemical Entities and
Biotechnological/Biological Entities);
International Council for
Harmonisation; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance entitled ‘‘Q11 Development
and Manufacture of Drug Substances—
Questions and Answers (Chemical
Entities and Biotechnological/Biological
Entities).’’ The guidance was prepared
under the auspices of the International
Council for Harmonisation (ICH),
formerly the International Conference
on Harmonisation. The guidance
consists of questions and answers that
were developed to clarify the principles
for selecting starting materials described
in the ICH guidance ‘‘Q11 Development
and Manufacture of Drug Substances’’,
published November 20, 2012. The
guidance is intended to provide
additional clarification and to promote
convergence on the considerations for
the selection and justification of starting
materials. The questions and answers
focus on chemical entity drug
substances, and provide
recommendations on the information
that should be provided in marketing
authorization applications and/or
master files to justify the starting
materials.
DATES: The announcement of the
guidance is published in the Federal
Register on February 26, 2018.
ADDRESSES: You may submit either
electronic or written comments on
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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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:
• 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–
2011–D–0436 for ‘‘Q11 Development
and Manufacture of Drug Substances—
Questions and Answers (Chemical
Entities and Biotechnological/Biological
Entities).’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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0910–0846
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expires
10/31/2020
10/31/2020
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/201523389.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,
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]]>Agencies
[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8278-8279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03849]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-1119; FDA-2010-N-0622; FDA-2011-N-0019; FDA-
2010-N-0594; FDA-2011-N-0016; FDA-2009-N-0501; FDA-2014-N-0222; FDA-
2017-D-0040; and FDA-2016-N-3585]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
Date approval
Title of collection OMB control No. expires
------------------------------------------------------------------------
Food Canning Establishment 0910-0037 10/31/2020
Registration, Process Filing, and
Recordkeeping for Acidified and
Thermally Processed Low-Acid
Foods............................
Color Additive Certification 0910-0216 10/31/2020
Requests and Recordkeeping.......
Customer/Partner Service Surveys.. 0910-0360 10/31/2020
Focus Groups as Used by the Food 0910-0497 10/31/2020
and Drug Administration..........
Recordkeeping and Records Access 0910-0560 10/31/2020
Requirements for Food Facilities.
Reporting and Recordkeeping 0910-0643 10/31/2020
Requirements for Reportable Food.
Guidance for Industry on User Fee 0910-0693 10/31/2020
Waivers, Reductions, and Refunds
for Drug and Biological Products.
[[Page 8279]]
Draft Guidance for Industry; How 0910-0845 10/31/2020
to Prepare a Pre-Request for
Designation (Pre-RFD)............
Character-Space-Limited Online 0910-0846 10/31/2020
Prescription Drug Communications.
------------------------------------------------------------------------
Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03849 Filed 2-23-18; 8:45 am]
BILLING CODE 4164-01-P
