83 FR 6866 - 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 32 (February 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 32 (February 15, 2018)
| Page Range | 6866-6866 | |
| FR Document | 2018-03128 |
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)] [Notices] [Page 6866] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03128] [[Page 6866]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0424; FDA-2014-N-0192; FDA-2008-N-0094; FDA- 2010-N-0062; FDA-2010-N-0588; FDA-2010-N-0110; FDA-2010-N-0493; FDA- 2017-N-1095; FDA-2013-D-0349; FDA-2016-N-2683] 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 ------------------------------------------------------------------------ Temporary Marketing Permit Applications. 0910-0133 11/30/2020 Establishing and Maintaining Lists of 0910-0509 11/30/2020 U.S. Milk Product Manufacturers/ Processors with Interest in Exporting.. Channels of Trade Policy for Commodities 0910-0562 11/30/2020 with Residues of Pesticide Chemicals for Which Tolerances Have been Revoked, Suspended, or Modified by the EPA...... Medical Devices; Exception from General 0910-0586 11/30/2020 Requirements for Informed Consent...... Exceptions or Alternatives to Labeling 0910-0614 11/30/2020 Requirements for Products Held by the Strategic National Stockpile........... Prescription Drug Advertisements........ 0910-0686 11/30/2020 Additional Criteria and Procedures for 0910-0688 11/30/2020 Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded........... Electronic Submission of Allegations of 0910-0769 11/30/2020 Regulatory Misconduct Associated with Medical Devices........................ Providing Waiver-Related Materials in 0910-0771 11/30/2020 Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format........... Data To Support Social and Behavioral 0910-0847 11/30/2020 Research as Used by the Food and Drug Administration......................... ------------------------------------------------------------------------ Dated: February 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03128 Filed 2-14-18; 8:45 am] BILLING CODE 4164-01-P
![6866 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices
DEPARTMENT OF HEALTH AND ACTION: Notice. collections recently approved by OMB
HUMAN SERVICES under section 3507 of the Paperwork
SUMMARY: The Food and Drug
Reduction Act of 1995 (44 U.S.C. 3507).
Food and Drug Administration Administration (FDA) is publishing a
The OMB control number and
list of information collections that have
been approved by the Office of expiration date of OMB approval for
[Docket Nos. FDA–2011–N–0424; FDA– each information collection are shown
2014–N–0192; FDA–2008–N–0094; FDA–
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995. in table 1. Copies of the supporting
2010–N–0062; FDA–2010–N–0588; FDA– statements for the information
2010–N–0110; FDA–2010–N–0493; FDA– FOR FURTHER INFORMATION CONTACT: Ila
2017–N–1095; FDA–2013–D–0349; FDA– S. Mizrachi, Office of Operations, Food collections are available on the internet
2016–N–2683] and Drug Administration, Three White at https://www.reginfo.gov/public/do/
Flint North, 10A–12M, 11601 PRAMain. An Agency may not conduct
Agency Information Collection Landsdown St., North Bethesda, MD or sponsor, and a person is not required
Activities; Announcement of Office of 20852, 301–796–7726, PRAStaff@ to respond to, a collection of
Management and Budget Approvals fda.hhs.gov. information unless it displays a
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: The
currently valid OMB control number.
HHS. following is a list of FDA information
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB Date approval
Title of collection control No. expires
Temporary Marketing Permit Applications .............................................................................................................. 0910–0133 11/30/2020
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors with Interest in Exporting .... 0910–0509 11/30/2020
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have
been Revoked, Suspended, or Modified by the EPA .......................................................................................... 0910–0562 11/30/2020
Medical Devices; Exception from General Requirements for Informed Consent ................................................... 0910–0586 11/30/2020
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile ...... 0910–0614 11/30/2020
Prescription Drug Advertisements ........................................................................................................................... 0910–0686 11/30/2020
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe
and Effective and Not Misbranded ...................................................................................................................... 0910–0688 11/30/2020
Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices ...................... 0910–0769 11/30/2020
Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market
Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format ........................... 0910–0771 11/30/2020
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration ...................... 0910–0847 11/30/2020
Dated: February 9, 2018. extension of a patent which claims that Electronic Submissions
Leslie Kux, human biological product.
Submit electronic comments in the
Associate Commissioner for Policy. DATES: Anyone with knowledge that any following way:
[FR Doc. 2018–03128 Filed 2–14–18; 8:45 am] of the dates as published (see the • Federal eRulemaking Portal:
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION section) are https://www.regulations.gov. Follow the
incorrect may submit either electronic instructions for submitting comments.
or written comments and ask for a Comments submitted electronically,
DEPARTMENT OF HEALTH AND redetermination by April 16, 2018.
HUMAN SERVICES including attachments, to https://
Furthermore, any interested person may www.regulations.gov will be posted to
petition FDA for a determination the docket unchanged. Because your
Food and Drug Administration
regarding whether the applicant for comment will be made public, you are
[Docket Nos. FDA–2014–E–2362 and FDA– extension acted with due diligence solely responsible for ensuring that your
2014–E–2363] during the regulatory review period by comment does not include any
August 14, 2018. See ‘‘Petitions’’ in the confidential information that you or a
Determination of Regulatory Review SUPPLEMENTARY INFORMATION section for third party may not wish to be posted,
Period for Purposes of Patent more information. such as medical information, your or
Extension; SYLVANT anyone else’s Social Security number, or
ADDRESSES: You may submit comments
AGENCY: Food and Drug Administration, as follows. Please note that late, confidential business information, such
HHS. untimely filed comments will not be as a manufacturing process. Please note
ACTION: Notice. considered. Electronic comments must that if you include your name, contact
be submitted on or before April 16, information, or other information that
SUMMARY: The Food and Drug 2018. The https://www.regulations.gov identifies you in the body of your
Administration (FDA) has determined electronic filing system will accept comments, that information will be
the regulatory review period for comments until midnight Eastern Time posted on https://www.regulations.gov.
sradovich on DSK3GMQ082PROD with NOTICES
SYLVANT and is publishing this notice at the end of April 16, 2018. Comments • If you want to submit a comment
of that determination as required by received by mail/hand delivery/courier with confidential information that you
law. FDA has made the determination (for written/paper submissions) will be do not wish to be made available to the
because of the submission of considered timely if they are public, submit the comment as a
applications to the Director of the U.S. postmarked or the delivery service written/paper submission and in the
Patent and Trademark Office (USPTO), acceptance receipt is on or before that manner detailed (see ‘‘Written/Paper
Department of Commerce, for the date. Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1](https://thefederalregister.org/doc/83_FR_6898/page/1.svg)
Document Created: 2018-02-15 00:21:19
Document Modified: 2018-02-15 00:21:19
| 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 6866 |
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