Document ID: FDA-2008-N-0334-0016
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
Posted Date: 2017-10-30T04:00Z

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50141-50142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23518]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Postmarketing Safety Reports for Human Drug and 
Biological Products: Electronic Submission Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the requirements for electronic submission 
of postmarketing safety reports for human drug and biological products.

DATES: Submit either electronic or written comments on the collection 
of information by December 29, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 29, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 29, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2008-N-0334 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Postmarketing Safety Reports for 
Human Drug and Biological Products: Electronic Submission 
Requirements.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an

[[Page 50142]]

existing collection of information, before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Postmarketing Safety Reports for Human Drug and Biological Products: 
Waivers From Electronic Submission Requirements--OMB Control Number 
0910-0770--Extension

    This information collection supports 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 
(the 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), 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    In table 1 of this document, 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 that approximately 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 a 
waiver annually under Sec. Sec.  314.80(g)(2) and 600.80(h)(2). We 
estimate that each waiver request will take approximately 1 hour to 
prepare and submit.

    Dated: October 24, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23518 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P