[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5784-5785]
[FR Doc No: 2018-02589]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0334]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Safety
Reports for Human Drug and Biological Products: Electronic Submission
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
12, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0770.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Postmarketing Safety Reports for Human Drug and Biological Products:
Waivers From Electronic Submission Requirements

OMB Control Number 0910-0770--Extension

    This information collection supports information collection found
in FDA regulations. In the Federal Register of June 10, 2014 (79 FR
33072), FDA published a final rule entitled ``Postmarketing Safety
Reports for Human Drug and Biological Products: Electronic Submission
Requirements.'' The final rule amended FDA's postmarketing safety
reporting regulations for human drug and biological products under 21
CFR parts 310, 314, and 600 and added part 329 to require that persons
subject to mandatory reporting requirements submit safety reports in an
electronic format that FDA can process, review, and archive.
Specifically, this includes:
     Manufacturers; packers; distributors; applicants with
approved new drug applications, abbreviated new drug applications, and
biologics licensing applications (BLAs); and those that market
prescription drugs for human use without an approved application must
submit postmarketing safety reports to the Agency (Sec. Sec.  310.305,
314.80, 314.98, and 600.80);
     manufacturers, packers, or distributors whose name appears
on the label of nonprescription human drug products marketed without an
approved application must report serious adverse events associated with
their products (section 760 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379aa)); and
     applicants with approved BLAs must submit biological lot
distribution reports to the Agency (Sec.  600.81).
    Under Sec. Sec.  310.305(e)(2), 314.80(g)(2), 329.100(c)(2),
600.80(h)(2), and 600.81(b)(2), of the regulations, those who are
subject to these postmarketing safety reporting requirements may
request a waiver from the electronic format requirement. While FDA
currently has OMB approval for the collection of postmarketing safety
reports,\1\ this information collection supports respondents seeking
waivers from submitting those reports in electronic format as required
by the regulations.
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    \1\ FDA currently has OMB approval for submission of
postmarketing safety reports under parts 310, 314, and 600. The
information collection for parts 310 and 314 is approved under OMB
Control Numbers 0910-0291 and 0910-0230. The information collection
for part 600 is approved under OMB Control Numbers 0910-0291 and
0910-0308. Submissions required by section 760 of the FD&C Act have
been approved under OMB Control Number 0910-0636.
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    In the Federal Register of October 30, 2017 (82 FR 50141), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.
    We therefore estimate the burden of this collection of information
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per     Total  hours
                                    respondents     respondent       responses       response
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310.305(e)(2)...................               1               1               1               1               1
314.80(g)(2)....................               5               1               5               1               5
329.100(c)(2)...................               1               1               1               1               1
600.80(h)(2)....................               5               1               5               1               5
600.81(b)(2)....................               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              13
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    In table 1, we estimate the burden associated with the submission
of waiver requests for postmarketing safety reports in electronic
format under Sec. Sec.  310.305(e)(2), 314.80(g)(2), 329.100(c)(2),
600.80(h)(2), and 600.81(b)(2). We expect few waiver requests. We
estimate only one manufacturer will request a waiver annually under
Sec. Sec.  310.305(e)(2), 329.100(c)(2), and 600.81(b)(2), and
approximately five manufacturers will request waivers annually under
Sec. Sec.  314.80(g)(2) and 600.80(h)(2). We estimate that each waiver
request takes 1 hour to prepare and submit. The burden for this
information collection has not increased since the last collection.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02589 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Notices]
[Page 140]
[FR Doc No: 2015-33064]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Thirty-Eighth Meeting: RTCA Special Committee (224) Airport
Security Access Control Systems

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Notice of Thirty-Eighth RTCA Special Committee 224 Meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of the
Thirty-Eighth RTCA Special Committee 224 meeting.

DATES: The meeting will be held January 28, 2016 from 10:00 a.m.-3:00
p.m.

ADDRESS: The meeting will be held at RTCA, Inc., 1150 18th Street NW.,
Suite 910, Washington, DC 20036, Tel:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or
Karan Hofmann, Program Director, RTCA, Inc<EMAIL_ADDRESS>(202)
330-0680.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of RTCA Special Committee 224. The agenda
will include the following:

Thursday, January 28, 2016

1. Welcome/Introductions/Administrative Remarks
2. Review/Approve Previous Meeting Summary
3. Report from the TSA
4. Report on Safe Skies on Document Distribution
5. Report on TSA Security Construction Guidelines progress
6. Review of DO-230G Sections
7. Review of DO-230H Sections
8. Action Items for Next Meeting
9. Time and Place of Next Meeting
10. Any Other Business
11. Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Plenary information will be
provided upon request. Persons who wish to present statements or obtain
information should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC, on December 29, 2015.
Latasha Robinson,
Management & Program Analyst, Next Generation, Enterprise Support
Services Division, Federal Aviation Administration.
[FR Doc. 2015-33064 Filed 12-31-15; 8:45 am]
 BILLING CODE 4910-13-P