[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23971-23973]
[FR Doc No: 2020-09175]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0424]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Safety Information Sharing by
Constituent Part Applicants for Combination Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 under the Postmarketing
Safety Reporting Rule for Combination Product for Constituent Part
Applicants to share specified adverse event information with one
another.

DATES: Submit either electronic or written comments on the collection
of information by June 29, 2020.

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 June 29, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 29, 2020. 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-0424 for ``Postmarketing Safety Information Sharing by
Constituent Part Applicants for Combination Products.'' 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.govinfo.gov/content/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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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.

Information Sharing Among Constituent Part Applicants--21 CFR 4.103

OMB Control Number 0910-0834--Extension

    This information collection request applies to ``constituent part
applicants'' as defined under 21 CFR 4.101 (i.e., any person holding an
application under which a constituent part (drug, device, or biological
product) of a combination product received marketing authorization if
the other constituent part(s) received marketing authorization under an
application held by a different person). Under this collection,
constituent part applicants must share safety information they receive
related to certain events with the other constituent part applicant(s)
and maintain associated records.\1\
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    \1\ The Postmarketing Safety Reporting (PMSR) information
collections for drugs, biological products, and devices found in
Sec. Sec.  314.80, 314.81, 600.80, 600.81, 606.170, 606.171, 803.50,
803.53, 803.56, 806.10, and 806.20 (21 CFR 314.80, 314.81, 600.80,
600.81, 606.170, 606.171, 803.50, 803.53, 803.56, 806.10, and
806.20) have already been approved and are in effect or their
extension is being sought separately as required, including with
respect to burden for combination products (reflected in the
authorization for OMB control number 0910-0834, but, therefore, not
addressed in this extension request). The pertinent PMSR information
collection provisions for Sec.  314.80(c) and (e), as well as for
Sec.  314.81(b) are approved under OMB control numbers 0910-0001,
0910-0230, and 0910-0291. The information collection provisions for
Sec. Sec.  600.80 and 600.81 are approved under OMB control number
0910-0308. Those for Sec.  606.170 are approved under OMB control
number 0910-0116. Those for Sec.  606.171 are approved under OMB
control number 0910-0458. The information collection provisions for
Sec. Sec.  803.50, 803.53, and 803.56 are approved under OMB control
numbers 0910-0291 and 0910-0437. The information collection
provisions for Sec. Sec.  806.10 and 806.20 are approved under OMB
control number 0910-0359.
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    FDA estimates the burden of this collection of information as
follows:

                                        Table 1--Estimated Annual Third-Party Disclosure and Recordkeeping Burden
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                                                                    Number of
                                                    Number of     disclosures/    Total annual
            21 CFR section/activity               respondents/     records per    disclosures/        Average burden per disclosure/        Total hours
                                                  recordkeepers    respondent/       records                  recordkeeping
                                                                  recordkeeper
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4.103, Sharing information with other                        33              18             594  0.35 (21 minutes)......................             208
 constituent part applicants.
4.103(b) and 4.105(a)(2), Records of                         33              18             594  0.1 (6 minutes)........................              59
 information shared by constituent part
 applicants.
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    Total......................................  ..............  ..............  ..............  .......................................             267
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    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. We note in this regard that FDA extended the compliance date
for 21 CFR part 4, subpart B, until July 2020 for most combination
products, and until January 2021 for the remainder, in response to
stakeholder feedback, to ensure that Combination Product Applicants
have sufficient time to update reporting and recordkeeping systems and
procedures.\2\ Consequently, entities subject to this rule have not yet
had to comply with this information request.
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    \2\ See Compliance Policy for Combination Product Postmarketing
Safety Reporting (April 2019) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-combination-product-postmarketing-safety-reporting).

    Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09175 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Notices]
[Pages 39293-39294]
[FR Doc No: 2019-17045]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER19-2065-001.
    Applicants: Midcontinent Independent System Operator, Inc. Ameren
Illinois Company.
    Description: Tariff Amendment: 2019-08-05 SA 2026 Ameren-Hannibal
Substitute 2nd Rev WDS to be effective 12/31/9998.
    Filed Date: 8/5/19.
    Accession Number: 20190805-5053.
    Comments Due: 5 p.m. ET 8/26/19.

    Docket Numbers: ER19-2252-001.
    Applicants: Stanton Energy Reliability Center, LLC.
    Description: Tariff Amendment: SERC Amendment to Application for
Market Based Rate Authorization to be effective 8/25/2019.
    Filed Date: 8/5/19.
    Accession Number: 20190805-5017.
    Comments Due: 5 p.m. ET 8/26/19.

    Docket Numbers: ER19-2529-000.
    Applicants: Black Hills Wyoming, LLC.
    Description: Sec.  205(d) Rate Filing: Request for Authorization of
Affiliate Transactions and Revisions to MBR Tariff to be effective 10/
2/2019.
    Filed Date: 8/2/19.
    Accession Number: 20190802-5157.
    Comments Due: 5 p.m. ET 8/23/19.

    Docket Numbers: ER19-2531-000.
    Applicants: DesertLink, LLC.
    Description: Sec.  205(d) Rate Filing: Amendments to DesertLinks
Formula Rate Protocols and Template to be effective 8/2/2019.
    Filed Date: 8/5/19.
    Accession Number: 20190805-5038.
    Comments Due: 5 p.m. ET 8/26/19.

    Docket Numbers: ER19-2532-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Tariff Cancellation: DEP-Notice of Cancellation of
CIAC w/Fayetteville to be effective 10/5/2019.
    Filed Date: 8/5/19.
    Accession Number: 20190805-5052.
    Comments Due: 5 p.m. ET 8/26/19.

    Docket Numbers: ER19-2533-000.
    Applicants: Vermont Transco LLC.
    Description: Notice of Cancellation of executed Large Generator
Interconnection Service Agreement No. 17 of Vermont Transco LLC.
    Filed Date: 8/5/19.
    Accession Number: 20190805-5068.
    Comments Due: 5 p.m. ET 8/26/19.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF19-1373-000; QF19-1374-000; QF19-1375-000; QF19-
1376-000; QF19-1377-000; QF19-1378-000; QF19-1379-000; QF19-1380-000;
QF19-1381-000; QF19-1382-000; QF19-1383-000; QF19-1384-000; QF19-1386-
000; QF19-1387-000; QF19-1388-000; QF19-1389-000; QF19-1390-000; QF19-
1391-000.
    Applicants: WGL Energy Systems, Inc.
    Description: Refund Report of WGL Energy Systems, Inc., et al.
    Filed Date: 8/5/19.
    Accession Number: 20190805-5031.
    Comments Due: 5 p.m. ET 8/26/19.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM19-3-000.
    Applicants: Prairie Power, Inc.
    Description: Supplement to July 11, 2019 Application of Prairie
Power, Inc. to Terminate Mandatory PURPA Purchase Obligation.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5128.
    Comments Due: 5 p.m. ET 8/27/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests,

service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information,
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 5, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-17045 Filed 8-8-19; 8:45 am]
 BILLING CODE 6717-01-P