83 FR 8278 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 38 (February 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 38 (February 26, 2018)
| Page Range | 8278-8279 | |
| FR Document | 2018-03849 |
[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)] [Notices] [Pages 8278-8279] From the Federal Register Online [www.thefederalregister.org] [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
![8278 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices
DCH-Performance Monitoring Database CDC also requests OMB approval to the data collection instrument(s) and a
(DCH–PMD). Forty-four previously conduct targeted, special purpose description of purpose and methods.
funded Partnership to Improve information collections on an as-needed CDC seeks approval for one year to
Community Health awardees will no basis. Due to substantial interest in the collect the necessary data. Also, CDC
longer be included in this collection due REACH program from a variety of requires cooperative agreement awardee
to funding cessation. stakeholders, CDC estimates that each
semi-annual progress reporting
The information system collects REACH awardee may receive an
participation, but voluntary for some
information to enable the accurate, invitation to participate in one special
special-purpose data collections.
reliable, uniform and timely submission purpose information collection.
to CDC of each awardee’s work plan and Methods for these data collections could There are no costs to respondents
progress reports. Monitoring allows CDC include telephone interviews, in-person other than their time. CDC estimates no
to: (1) Determine whether an awardee is interviews, Web-based surveys, or change to the average burden per
meeting performance goals; (2) make paper-and-pencil surveys. CDC will response for routine, semi-annual
adjustments in the type and level of submit each special-purpose reporting (estimated at three hours). The
technical assistance provided to information collection request to OMB total estimated annualized burden hours
awardees; and (3) provide oversight of for approval through the Change for an additional year of information
the use of federal funds. Request mechanism, and will include collection are 588.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
DCH Program Awardees (state, local and DCH MIS: Semi-annual reporting .................. 18 2 3
tribal government sector). Special Data Request .................................... 18 1 6
DCH Program Awardees (private sector) ....... DCH MIS: Semi-annual reporting .................. 31 2 3
Special Data Request .................................... 31 1 6
Leroy A. Richardson, DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: Ila
Chief, Information Collection Review Office, HUMAN SERVICES S. Mizrachi, Office of Operations, Food
Office of Scientific Integrity, Office of the and Drug Administration, Three White
Associate Director for Science, Office of the Food and Drug Administration Flint North, 10A–12M, 11601
Director, Centers for Disease Control and Landsdown St., North Bethesda, MD
Prevention. [Docket Nos. FDA–2013–N–1119; FDA– 20852, 301–796–7726, PRAStaff@
[FR Doc. 2018–03803 Filed 2–23–18; 8:45 am] 2010–N–0622; FDA–2011–N–0019; FDA– fda.hhs.gov.
BILLING CODE 4163–18–P 2010–N–0594; FDA–2011–N–0016; FDA–
2009–N–0501; FDA–2014–N–0222; FDA–
SUPPLEMENTARY INFORMATION: The
2017–D–0040; and FDA–2016–N–3585] following is a list of FDA information
collections recently approved by OMB
Agency Information Collection under section 3507 of the Paperwork
Activities; Announcement of Office of Reduction Act of 1995 (44 U.S.C. 3507).
Management and Budget Approvals The OMB control number and
expiration date of OMB approval for
AGENCY: Food and Drug Administration, each information collection are shown
HHS. in table 1. Copies of the supporting
ACTION: Notice. statements for the information
collections are available on the internet
SUMMARY: The Food and Drug at https://www.reginfo.gov/public/do/
Administration (FDA) is publishing a PRAMain. An Agency may not conduct
list of information collections that have or sponsor, and a person is not required
been approved by the Office of to respond to, a collection of
Management and Budget (OMB) under information unless it displays a
the Paperwork Reduction Act of 1995. 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 Registration, Process Filing, and Recordkeeping for Acidified and Ther-
mally Processed Low-Acid Foods ............................................................................................................ 0910–0037 10/31/2020
daltland on DSKBBV9HB2PROD with NOTICES
Color Additive Certification Requests and Recordkeeping ......................................................................... 0910–0216 10/31/2020
Customer/Partner Service Surveys ............................................................................................................. 0910–0360 10/31/2020
Focus Groups as Used by the Food and Drug Administration ................................................................... 0910–0497 10/31/2020
Recordkeeping and Records Access Requirements for Food Facilities ..................................................... 0910–0560 10/31/2020
Reporting and Recordkeeping Requirements for Reportable Food ............................................................ 0910–0643 10/31/2020
Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Prod-
ucts ........................................................................................................................................................... 0910–0693 10/31/2020
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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
Date approval
Title of collection OMB control No. expires
Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD) .......................... 0910–0845 10/31/2020
Character-Space-Limited Online Prescription Drug Communications ........................................................ 0910–0846 10/31/2020
Dated: February 21, 2018. Agency guidances at any time as https://www.regulations.gov or at the
Leslie Kux, follows: Dockets Management Staff between 9
Associate Commissioner for Policy. a.m. and 4 p.m., Monday through
Electronic Submissions
[FR Doc. 2018–03849 Filed 2–23–18; 8:45 am] Friday.
BILLING CODE 4164–01–P
Submit electronic comments in the • Confidential Submissions—To
following way: submit a comment with confidential
• Federal eRulemaking Portal: information that you do not wish to be
DEPARTMENT OF HEALTH AND https://www.regulations.gov. Follow the made publicly available, submit your
HUMAN SERVICES instructions for submitting comments. comments only as a written/paper
Comments submitted electronically, submission. You should submit two
Food and Drug Administration including attachments, to https:// copies total. One copy will include the
www.regulations.gov will be posted to information you claim to be confidential
[Docket No. FDA–2011–D–0436]
the docket unchanged. Because your with a heading or cover note that states
Q11 Development and Manufacture of comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
Drug Substances—Questions and solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
Answers (Chemical Entities and comment does not include any Agency will review this copy, including
Biotechnological/Biological Entities); confidential information that you or a the claimed confidential information, in
International Council for third party may not wish to be posted, its consideration of comments. The
Harmonisation; Guidance for Industry; such as medical information, your or second copy, which will have the
Availability anyone else’s Social Security number, or claimed confidential information
confidential business information, such redacted/blacked out, will be available
AGENCY: Food and Drug Administration, as a manufacturing process. Please note for public viewing and posted on
HHS. that if you include your name, contact https://www.regulations.gov. Submit
ACTION: Notice of availability. information, or other information that both copies to the Dockets Management
identifies you in the body of your Staff. If you do not wish your name and
SUMMARY: The Food and Drug
comments, that information will be contact information to be made publicly
Administration (FDA or Agency) is
posted on https://www.regulations.gov. available, you can provide this
announcing the availability of a
• If you want to submit a comment information on the cover sheet and not
guidance entitled ‘‘Q11 Development
with confidential information that you in the body of your comments and you
and Manufacture of Drug Substances—
do not wish to be made available to the must identify this information as
Questions and Answers (Chemical
public, submit the comment as a ‘‘confidential.’’ Any information marked
Entities and Biotechnological/Biological
written/paper submission and in the as ‘‘confidential’’ will not be disclosed
Entities).’’ The guidance was prepared
under the auspices of the International manner detailed (see ‘‘Written/Paper except in accordance with 21 CFR 10.20
Council for Harmonisation (ICH), Submissions’’ and ‘‘Instructions’’). and other applicable disclosure law. For
formerly the International Conference more information about FDA’s posting
Written/Paper Submissions
on Harmonisation. The guidance of comments to public dockets, see 80
Submit written/paper submissions as FR 56469, September 18, 2015, or access
consists of questions and answers that
follows: the information at: https://www.gpo.gov/
were developed to clarify the principles • Mail/Hand delivery/Courier (for
for selecting starting materials described fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submissions): Dockets 23389.pdf.
in the ICH guidance ‘‘Q11 Development
Management Staff (HFA–305), Food and Docket: For access to the docket to
and Manufacture of Drug Substances’’,
Drug Administration, 5630 Fishers read background documents or the
published November 20, 2012. The
Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments
guidance is intended to provide
• For written/paper comments received, go to https://
additional clarification and to promote
submitted to the Dockets Management www.regulations.gov and insert the
convergence on the considerations for
Staff, FDA will post your comment, as docket number, found in brackets in the
the selection and justification of starting
well as any attachments, except for heading of this document, into the
materials. The questions and answers
information submitted, marked and ‘‘Search’’ box and follow the prompts
focus on chemical entity drug
identified, as confidential, if submitted and/or go to the Dockets Management
substances, and provide
as detailed in ‘‘Instructions.’’ Staff, 5630 Fishers Lane, Rm. 1061,
recommendations on the information Instructions: All submissions received
that should be provided in marketing Rockville, MD 20852.
must include the Docket No. FDA– You may submit comments on any
authorization applications and/or 2011–D–0436 for ‘‘Q11 Development guidance at any time (see 21 CFR
daltland on DSKBBV9HB2PROD with NOTICES
master files to justify the starting and Manufacture of Drug Substances— 10.115(g)(5)).
materials. Questions and Answers (Chemical Submit written requests for single
DATES: The announcement of the Entities and Biotechnological/Biological copies of this guidance to the Division
guidance is published in the Federal Entities).’’ Received comments will be of Drug Information, Center for Drug
Register on February 26, 2018. placed in the docket and, except for Evaluation and Research, Food and
ADDRESSES: You may submit either those submitted as ‘‘Confidential Drug Administration, 10001 New
electronic or written comments on Submissions,’’ publicly viewable at Hampshire Ave., Hillandale Building,
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Document Created: 2018-02-24 01:00:25
Document Modified: 2018-02-24 01:00:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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] | |
| FR Citation | 83 FR 8278 |
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