[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5784-5785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 202-395-7285, 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, 301-796-5733, 
[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:

[[Page 5785]]



                                 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
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    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


