Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 57450-57451 [2019-23251]
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
annually, and assume each notification
requires 16 hours to prepare and submit.
Finally, the guidance recommends
developing a Plan for each individual
manufacturing facility as well as a
broader Plan that addresses multiple
sites within the organization. For
purposes of this information collection
analysis, we consider the Plan for an
individual manufacturing facility and
the broader Plan to comprise one Plan
for each manufacturer. Based on
available data on the number of
manufacturers that would be covered by
the guidance, we previously estimated
70 manufacturers will develop a Plan as
recommended by the guidance (i.e., one
Plan per manufacturer, to include all
manufacturing facilities, sites, and drug
products) and that each Plan would take
approximately 500 hours to develop.
Upon development of the plan,
however, we believe fewer hours are
necessary to maintain and update it as
needed. As FDA issued the guidance in
2011, we now assume that most
respondents have developed the
recommended plan, and therefore we
limit our current burden estimate to
updates and maintenance. Accordingly,
we have reduced our estimate by half,
reasoning that, although it takes fewer
hours for updates and maintenance,
new respondents may choose to adopt
recommendations found in the
guidance.
Dated: October 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23272 Filed 10–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4310]
Allergan Pharmaceuticals
International, LTD; Withdrawal of
Approval of a New Drug Application for
LO MINASTRIN FE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
withdrawing approval of a new drug
application (NDA) for LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01
milligrams (mg); ethinyl estradiol and
norethindrone acetate tablets, 0.01 mg/
1mg; and ferrous fumarate tablets, 75
mg), held by Allergan Pharmaceuticals
International, LTD, c/o Allergan Sales,
LLC, 5 Giralda Farms, Madison, NJ
07940 (Allergan). Allergan notified the
Agency in writing that the drug product
was no longer marketed and requested
that the approval of the application be
withdrawn.
Approval is withdrawn as of
November 25, 2019.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
Allergan
has informed FDA that LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01 mg;
ethinyl estradiol and norethindrone
acetate tablets, 0.01 mg/1 mg; and
ferrous fumarate tablets, 75 mg) is no
longer marketed and has requested that
FDA withdraw approval of NDA 204654
under the process in § 314.150(c) (21
CFR 314.150(c)). Allergan has also, by
its request, waived its opportunity for a
hearing. Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
Therefore, approval of NDA 204654,
and all amendments and supplements
thereto, is hereby withdrawn as of
November 25, 2019. Approval of the
entire application is withdrawn,
including any strengths and dosage
forms inadvertently missing from this
notice. Introduction or delivery for
introduction into interstate commerce of
a product without an approved new
drug application violates section 301(a)
and (d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Any Lo Minastrin Fe that is in inventory
on November 25, 2019 may continue to
be dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
SUPPLEMENTARY INFORMATION:
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23309 Filed 10–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–3163; FDA–
2012–D–0429; FDA–2012–D–0049; FDA–
2018–N–3031; FDA–2011–D–0125; FDA–
2018–N–4428; FDA–2012–N–0560; FDA–
2010–N–0414; FDA–2012–N–1203; and
FDA–2019–N–0430]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
publishing a list of information
collections that have been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA).
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional
Pieces ...................................................................................................................................................................
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products .......................................................................................................................................................................
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expires
0910–0875
9/30/2021
0910–0731
8/31/2022
Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
57451
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB
control No.
Title of collection
Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the
Federal Food, Drug, and Cosmetic Act ...............................................................................................................
Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for
Domestic Manufacturers and Importers of Tobacco ...........................................................................................
Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United
States as of ..........................................................................................................................................................
February 15, 2007 ...................................................................................................................................................
Medicated Feed Mill License Application ................................................................................................................
Guidance on Informed Consent for In Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not
Individually Identifiable .........................................................................................................................................
Manufactured Food Regulatory Program Standards ..............................................................................................
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements ...........................................................................................................................................
Generic Clearance for Quick Turnaround Testing of Communication Effectiveness .............................................
Dated: October 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23251 Filed 10–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4560]
Pediatric Stakeholder Meeting; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration’s (FDA or the Agency)
Office of Pediatric Therapeutics (OPT),
the Center for Drug Evaluation and
Research (CDER) and the Center for
Biologics Evaluation and Research
(CBER) are announcing a public meeting
seeking input from patient/parent
groups, consumer groups, regulated
industry, academia, and other interested
parties to obtain any recommendations
or information relevant to the report to
Congress that FDA is required to submit
concerning pediatrics, as outlined in
section 508 of the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (see the SUPPLEMENTARY
INFORMATION section for additional
background information).
DATES: The public meeting will be held
on November 21, 2019, from 9 a.m. to
3 p.m. Registration to attend the meeting
should be received by November 15,
2019. Onsite registration on the day of
the meeting will be based on space
availability. Submit either electronic or
written comments on the public meeting
by December 19, 2019. See the
SUMMARY:
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SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(1503–A), Silver Spring, MD 20993–
0002. Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For information on parking
and security procedures, please refer to
https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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 19, 2019.
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 manufacturing process. Please note
that if you include your name, contact
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expires
0910–0732
8/31/2022
0910–0749
8/31/2022
0910–0775
0910–0337
8/31/2022
9/30/2022
0910–0582
0910–0601
9/30/2022
9/30/2022
0910–0661
0910–0876
9/30/2022
9/30/2022
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–
2019–N–4560 for ‘‘Pediatric Stakeholder
Meeting.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docker
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
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[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57450-57451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23251]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-3163; FDA-2012-D-0429; FDA-2012-D-0049; FDA-
2018-N-3031; FDA-2011-D-0125; FDA-2018-N-4428; FDA-2012-N-0560; FDA-
2010-N-0414; FDA-2012-N-1203; and FDA-2019-N-0430]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
a list of information collections that have been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995 (PRA).
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Physician Interpretation of Information 0910-0875 9/30/2021
About Prescription Drugs in Scientific
Publications Versus Promotional Pieces.
Guidance on Meetings with Industry and 0910-0731 8/31/2022
Investigators on the Research and
Development of Tobacco Products........
[[Page 57451]]
Reporting Harmful and Potentially 0910-0732 8/31/2022
Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the
Federal Food, Drug, and Cosmetic Act...
Tobacco Products, User Fees, 0910-0749 8/31/2022
Requirements for the Submission of Data
Needed to Calculate User Fees for
Domestic Manufacturers and Importers of
Tobacco................................
Guidance for Industry on Establishing 0910-0775 8/31/2022
That a Tobacco Product Was Commercially
Marketed in the United States as of....
February 15, 2007.......................
Medicated Feed Mill License Application. 0910-0337 9/30/2022
Guidance on Informed Consent for In 0910-0582 9/30/2022
Vitro Diagnostic Studies Using Leftover
Human Specimens That Are Not
Individually Identifiable..............
Manufactured Food Regulatory Program 0910-0601 9/30/2022
Standards..............................
Information to Accompany Humanitarian 0910-0661 9/30/2022
Device Exemption Applications and
Annual Distribution Number Reporting
Requirements...........................
Generic Clearance for Quick Turnaround 0910-0876 9/30/2022
Testing of Communication Effectiveness.
------------------------------------------------------------------------
Dated: October 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23251 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P
