Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements, 50141-50142 [2017-23518]
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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
Institutes of Health/National Library of
Medicine or a similar source. When
providing this information, please
provide weblinks to where this
information is publicly available. This
information may assist in FDA’s
determination of which SDOs may
fulfill the statutory requirements.
Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017–23519 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
Electronic Submissions
50141
comments only as a written/paper
submission. You should submit two
Submit electronic comments in the
copies total. One copy will include the
following way:
• Federal eRulemaking Portal: https:// information you claim to be confidential
with a heading or cover note that states
www.regulations.gov. Follow the
‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments.
CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically,
Agency will review this copy, including
including attachments, to https://
the claimed confidential information, in
www.regulations.gov will be posted to
its consideration of comments. The
the docket unchanged. Because your
second copy, which will have the
comment will be made public, you are
claimed confidential information
solely responsible for ensuring that your
redacted/blacked out, will be available
comment does not include any
for public viewing and posted on
confidential information that you or a
https://www.regulations.gov. Submit
third party may not wish to be posted,
both copies to the Dockets Management
such as medical information, your or
Staff. If you do not wish your name and
anyone else’s Social Security number, or
contact information to be made publicly
confidential business information, such
available, you can provide this
as a manufacturing process. Please note
information on the cover sheet and not
that if you include your name, contact
in the body of your comments and you
information, or other information that
must identify this information as
identifies you in the body of your
‘‘confidential.’’ Any information marked
comments, that information will be
as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov.
except in accordance with 21 CFR 10.20
• If you want to submit a comment
and other applicable disclosure law. For
with confidential information that you
more information about FDA’s posting
do not wish to be made available to the
of comments to public dockets, see 80
public, submit the comment as a
FR 56469, September 18, 2015, or access
written/paper submission and in the
the information at: https://www.gpo.gov/
manner detailed (see ‘‘Written/Paper
fdsys/pkg/FR-2015-09-18/pdf/2015Submissions’’ and ‘‘Instructions’’).
23389.pdf.
Docket: For access to the docket to
Written/Paper Submissions
read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
follows:
received, go to https://
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
written/paper submissions): Dockets
docket number, found in brackets in the
Management Staff (HFA–305), Food and
heading of this document, into the
Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Dockets Management
• For written/paper comments
Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management
Rockville, MD 20852.
Staff, FDA will post your comment, as
FOR FURTHER INFORMATION CONTACT:
well as any attachments, except for
Domini Bean, Office of Operations,
information submitted, marked and
Food and Drug Administration, Three
identified, as confidential, if submitted
White Flint North, 10A–12M, 11601
as detailed in ‘‘Instructions.’’
Instructions: All submissions received Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
must include the Docket No. FDA–
fda.hhs.gov.
2008–N–0334 for ‘‘Agency Information
SUPPLEMENTARY INFORMATION: Under the
Collection Activities; Proposed
PRA (44 U.S.C. 3501–3520), Federal
Collection; Comment Request;
Postmarketing Safety Reports for Human Agencies must obtain approval from the
Drug and Biological Products: Electronic Office of Management and Budget
(OMB) for each collection of
Submission Requirements.’’ Received
information they conduct or sponsor.
comments, those filed in a timely
manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
in the docket and, except for those
1320.3(c) and includes Agency requests
submitted as ‘‘Confidential
or requirements that members of the
Submissions,’’ publicly viewable at
public submit reports, keep records, or
https://www.regulations.gov or at the
provide information to a third party.
Dockets Management Staff between 9
Section 3506(c)(2)(A) of the PRA (44
a.m. and 4 p.m., Monday through
U.S.C. 3506(c)(2)(A)) requires Federal
Friday.
Agencies to provide a 60-day notice in
• Confidential Submissions—To
the Federal Register concerning each
submit a comment with confidential
proposed collection of information,
information that you do not wish to be
including each proposed extension of an
made publicly available, submit your
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50142
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
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 (§§ 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 (§ 600.81).
Under §§ 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
310.305(e)(2) .......................................................................
314.80(g)(2) .........................................................................
329.100(c)(2) ........................................................................
600.80(h)(2) .........................................................................
600.81(b)(2) .........................................................................
1
5
1
5
1
1
1
1
1
1
1
5
1
5
1
1
1
1
1
1
1
5
1
5
1
Total ..............................................................................
........................
........................
........................
........................
13
sradovich on DSK3GMQ082PROD with NOTICES
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 §§ 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
§§ 310.305(e)(2), 329.100(c)(2), and
600.81(b)(2), and approximately five
manufacturers will request a waiver
annually under §§ 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.
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
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–23518 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2012–D–0880]
Assessing User Fees Under the
Generic Drug User Fee Amendments of
2017; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
SUMMARY:
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FD&C Act have been approved under OMB control
number 0910–0636.
E:\FR\FM\30OCN1.SGM
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]]>Agencies
[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
