82 FR 51424 - 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 82, Issue 213 (November 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 213 (November 6, 2017)
| Page Range | 51424-51425 | |
| FR Document | 2017-24121 |
[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)] [Notices] [Pages 51424-51425] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24121] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-N-0258; FDA-2010-N-0623; FDA-2007-N-0383; FDA- 2009-N-0360; FDA-2016-N-4620; FDA-2013-N-1496; FDA-2007-N-0220; FDA- 2017-N-1848; FDA-2017-N-1066; FDA-2015-D-3327; FDA-2011-D-0689] 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 ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Submission of Petitions: Food Additive, 0910-0016 9/30/2020 Color Additive (Including Labeling), Submission to Information to a Master File in Support of Petitions; and Electronic Submission Using FDA 3053... Voluntary Cosmetic Registration Program. 0910-0027 9/30/2020 Radioactive Drug Research Committees.... 0910-0053 9/30/2020 FDA Safety Communication Readership 0910-0341 9/30/2020 Survey................................. Medical Devices; Reports for Corrections 0910-0359 9/30/2020 and Removals........................... Generic FDA Rapid Response Surveys...... 0910-0500 9/30/2020 Guidance for Industry: Pharmacogenomic 0910-0557 9/30/2020 Data Submissions....................... Cosmetic Labeling Regulations........... 0910-0599 9/30/2020 Annual Reporting for Custom Device 0910-0767 9/30/2020 Exemption.............................. GFI: E6(R2) Good Clinical Practice; 0910-0843 9/30/2020 International Council for Harmonisation DeNovo Classification Process 0910-0844 9/30/2020 (Evaluation of Automatic Class II Designation)........................... ------------------------------------------------------------------------ Dated: November 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24121 Filed 11-3-17; 8:45 am] BILLING CODE 4164-01-P
![51424 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices
ANDA submissions, as well as the pre- consideration that much of this content gathered for the ANDA submission. We
submission certification statement is related to information already invite comments on these estimates.
(referenced in table 1), takes into
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
Activity responses per burden per
respondents responses hours
respondent response
Pre-Submission of Facility Information ................................ 220 1.25 275 1.1 303
Certification statement submitted with the ANDA ............... 198 1.25 248 4 990
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: Ila
HUMAN SERVICES S. Mizrachi, Office of Operations, Food
Persons with access to the internet and Drug Administration, Three White
may obtain the draft guidance at either Food and Drug Administration Flint North, 10A–12M, 11601
https://www.fda.gov/Drugs/Guidance Landsdown St., North Bethesda, MD
[Docket Nos. FDA–2010–N–0258; FDA–
ComplianceRegulatoryInformation/ 20852, 301–796–7726, PRAStaff@
2010–N–0623; FDA–2007–N–0383; FDA–
Guidances/default.htm or https://www. 2009–N–0360; FDA–2016–N–4620; FDA– fda.hhs.gov.
regulations.gov. 2013–N–1496; FDA–2007–N–0220; FDA– SUPPLEMENTARY INFORMATION: The
Dated: October 31, 2017. 2017–N–1848; FDA–2017–N–1066; FDA– following is a list of FDA information
2015–D–3327; FDA–2011–D–0689]
Anna K. Abram, collections recently approved by OMB
Deputy Commissioner for Policy, Planning, Agency Information Collection under section 3507 of the Paperwork
Legislation, and Analysis. Activities; Announcement of Office of Reduction Act of 1995 (44 U.S.C. 3507).
[FR Doc. 2017–24099 Filed 11–3–17; 8:45 am] Management and Budget Approvals The OMB control number and
BILLING CODE 4164–01–P
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
OMB
Title of collection approval
control No. expires
Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission to Information to a
Master File in Support of Petitions; and Electronic Submission Using FDA 3053 ............................................. 0910–0016 9/30/2020
Voluntary Cosmetic Registration Program .............................................................................................................. 0910–0027 9/30/2020
Radioactive Drug Research Committees ................................................................................................................ 0910–0053 9/30/2020
FDA Safety Communication Readership Survey .................................................................................................... 0910–0341 9/30/2020
Medical Devices; Reports for Corrections and Removals ...................................................................................... 0910–0359 9/30/2020
Generic FDA Rapid Response Surveys .................................................................................................................. 0910–0500 9/30/2020
Guidance for Industry: Pharmacogenomic Data Submissions ................................................................................ 0910–0557 9/30/2020
Cosmetic Labeling Regulations ............................................................................................................................... 0910–0599 9/30/2020
Annual Reporting for Custom Device Exemption .................................................................................................... 0910–0767 9/30/2020
GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation ....................................................... 0910–0843 9/30/2020
DeNovo Classification Process (Evaluation of Automatic Class II Designation) .................................................... 0910–0844 9/30/2020
Dated: November 1, 2017.
Pmangrum on DSK3GDR082PROD with NOTICES
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24121 Filed 11–3–17; 8:45 am]
BILLING CODE 4164–01–P
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![Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51425
DEPARTMENT OF HEALTH AND the docket unchanged. Because your redacted/blacked out, will be available
HUMAN SERVICES comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
Food and Drug Administration comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
[Docket No. FDA–2011–N–0403]
third party may not wish to be posted, contact information to be made publicly
Agency Information Collection such as medical information, your or available, you can provide this
Activities; Proposed Collection; anyone else’s Social Security number, or information on the cover sheet and not
Comment Request; Substantiation for confidential business information, such in the body of your comments and you
Dietary Supplement Claims Made as a manufacturing process. Please note
must identify this information as
Under the Federal Food, Drug, and that if you include your name, contact
‘‘confidential.’’ Any information marked
Cosmetic Act information, or other information that
identifies you in the body of your as ‘‘confidential’’ will not be disclosed
comments, that information will be except in accordance with 21 CFR 10.20
AGENCY: Food and Drug Administration,
HHS. posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment more information about FDA’s posting
ACTION: Notice. of comments to public dockets, see 80
with confidential information that you
SUMMARY: The Food and Drug do not wish to be made available to the FR 56469, September 18, 2015, or access
Administration (FDA or Agency) is public, submit the comment as a the information at: https://www.gpo.gov/
announcing an opportunity for public written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
comment on the proposed collection of manner detailed (see ‘‘Written/Paper 23389.pdf.
certain information by the Agency. Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Under the Paperwork Reduction Act of Written/Paper Submissions read background documents or the
1995 (PRA), Federal Agencies are electronic and written/paper comments
required to publish notice in the Submit written/paper submissions as
follows: received, go to https://
Federal Register concerning each www.regulations.gov and insert the
proposed collection of information, • Mail/Hand delivery/Courier (for
written/paper submissions): Dockets docket number, found in brackets in the
including each proposed extension of an heading of this document, into the
existing collection of information, and Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
to allow 60 days for public comment in
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
response to the notice. This notice
solicits comments on the information • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management Rockville, MD 20852.
collection provisions of the Federal
Food, Drug, and Cosmetic Act (the Staff, FDA will post your comment, as
well as any attachments, except for FOR FURTHER INFORMATION CONTACT: Ila
FD&C Act) and the guidance entitled Mizrachi, Office of Operations, Food
information submitted, marked and
‘‘Guidance for Industry: Substantiation and Drug Administration, Three White
identified, as confidential, if submitted
for Dietary Supplement Claims Made Flint North, 10A–12M, 11601
as detailed in ‘‘Instructions.’’
Under Section 403(r)(6) of the Federal Landsdown St., North Bethesda, MD
Instructions: All submissions received
Food, Drug, and Cosmetic Act.’’ 20852, 301–796–7726, PRAStaff@
must include the Docket No. FDA–
DATES: Submit either electronic or 2011–N–0403 for ‘‘Substantiation for fda.hhs.gov.
written comments on the collection of Dietary Supplement Claims Made Under
information by January 5, 2018. the Federal Food, Drug, and Cosmetic SUPPLEMENTARY INFORMATION: Under the
ADDRESSES: You may submit comments Act.’’ Received comments, those filed in PRA (44 U.S.C. 3501–3520), Federal
as follows. Please note that late, a timely manner (see ADDRESSES), will Agencies must obtain approval from the
untimely filed comments will not be be placed in the docket and, except for Office of Management and Budget
considered. Electronic comments must those submitted as ‘‘Confidential (OMB) for each collection of
be submitted on or before January 5, Submissions,’’ publicly viewable at information they conduct or sponsor.
2018. The https://www.regulations.gov https://www.regulations.gov or at the ‘‘Collection of information’’ is defined
electronic filing system will accept Dockets Management Staff between 9 in 44 U.S.C. 3502(3) and 5 CFR
comments until midnight Eastern Time a.m. and 4 p.m., Monday through 1320.3(c) and includes Agency requests
at the end of January 5, 2018. Comments Friday. or requirements that members of the
received by mail/hand delivery/courier • Confidential Submissions—To public submit reports, keep records, or
(for written/paper submissions) will be submit a comment with confidential provide information to a third party.
considered timely if they are information that you do not wish to be Section 3506(c)(2)(A) of the PRA (44
postmarked or the delivery service made publicly available, submit your U.S.C. 3506(c)(2)(A)) requires Federal
acceptance receipt is on or before that comments only as a written/paper Agencies to provide a 60-day notice in
date. submission. You should submit two the Federal Register concerning each
copies total. One copy will include the proposed collection of information,
Electronic Submissions
information you claim to be confidential including each proposed extension of an
Pmangrum on DSK3GDR082PROD with NOTICES
Submit electronic comments in the with a heading or cover note that states existing collection of information,
following way: ‘‘THIS DOCUMENT CONTAINS before submitting the collection to OMB
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The for approval. To comply with this
https://www.regulations.gov. Follow the Agency will review this copy, including
requirement, FDA is publishing notice
instructions for submitting comments. the claimed confidential information, in
of the proposed collection of
Comments submitted electronically, its consideration of comments. The
information set forth in this document.
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
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Document Created: 2017-11-07 10:30:42
Document Modified: 2017-11-07 10:30:42
| 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 | 82 FR 51424 |
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