Agency Information Collection Activities: Submission for OMB Review; Comment Request;, 70557 [2019-27667]
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Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–287–19]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request;
ACTION:
Partial Withdrawal.
On Tuesday, December 17, 2019 (84
FR 68936), the Centers of Medicare &
Medicaid Services (CMS) published a
Notice document titled ‘‘Agency
Information Collection Activities:
Submission for OMB Review; Comment
Request.’’ That notice invited public
comments on four separate information
collection requests. Through the
publication of this document, we are
withdrawing the portion of the notice
requesting public comment on the
information collection request titled
‘‘Home Office Cost Statement’’ Form
number: CMS–287–19 (OMB control
number: 0938–0202). The notice for
CMS–287–19 published in error. We
will resubmit it for public comment at
a later date. The original comment
period for the other notices that
published on December 17, 2019 (84 FR
68936) remains in effect and ends
January 16, 2020.
Dated: December 18, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–27667 Filed 12–20–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5743]
Importation of Certain Food and Drug
Administration-Approved Human
Prescription Drugs, Including
Biological Products, Under Section
801(d)(1)(B) of the Federal Food, Drug,
and Cosmetic Act; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
lotter on DSKBCFDHB2PROD with NOTICES
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Importation of Certain FDA-Approved
Human Prescription Drugs, Including
SUMMARY:
VerDate Sep<11>2014
19:32 Dec 20, 2019
Jkt 250001
Biological Products, under Section
801(d)(1)(B) of the Federal Food, Drug,
and Cosmetic Act.’’ This draft guidance
describes procedures to obtain a
National Drug Code (NDC) for an FDAapproved prescription drug that is
imported into the United States in
compliance with the Federal Food,
Drug, and Cosmetic Act (FD&C Act),
which would provide an additional
avenue through which drugs could be
sold at a lower cost in the U.S. market.
This draft guidance is intended to
address certain challenges in the private
market faced by manufacturers seeking
to sell their drugs at lower costs.
DATES: Submit either electronic or
written comments on the draft guidance
by February 21, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
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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–D–5743 for ‘‘Importation of
Certain FDA-Approved Human
Prescription Drugs, Including Biological
Products, under Section 801(d)(1)(B) of
the Federal Food, Drug, and Cosmetic
Act.’’ Received comments 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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Page 70557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27667]
[[Page 70557]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-287-19]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request;
ACTION: Partial Withdrawal.
-----------------------------------------------------------------------
On Tuesday, December 17, 2019 (84 FR 68936), the Centers of
Medicare & Medicaid Services (CMS) published a Notice document titled
``Agency Information Collection Activities: Submission for OMB Review;
Comment Request.'' That notice invited public comments on four separate
information collection requests. Through the publication of this
document, we are withdrawing the portion of the notice requesting
public comment on the information collection request titled ``Home
Office Cost Statement'' Form number: CMS-287-19 (OMB control number:
0938-0202). The notice for CMS-287-19 published in error. We will
resubmit it for public comment at a later date. The original comment
period for the other notices that published on December 17, 2019 (84 FR
68936) remains in effect and ends January 16, 2020.
Dated: December 18, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-27667 Filed 12-20-19; 8:45 am]
BILLING CODE 4120-01-P
