National Cancer Institute; Notice of Meeting, 70559 [2019-27582]
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Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
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distinguish the appearance of an MMA
product? We also request comment
about alternative labeling approaches
that would display the required
information with equal prominence but
may result in lower costs.
6. The draft guidance describes
procedures for manufacturers of drug
products approved under new drug
applications or biologics license
applications to obtain an additional
NDC for an MMA product. FDA is
interested as to whether manufacturers
of generic drugs approved under an
abbreviated new drug application
confront similar pricing issues such that
it would be appropriate to provide
guidance on a similar approach for
generic drugs. To the extent that
interested parties believe that different
considerations should apply to such an
approach for generic drugs from those
described in the draft guidance, input is
requested on that as well.
7. There are complex considerations
that impact biosimilar development,
market entry, and uptake. We are
interested in the possible impacts of
MMA products that are biological
products on biosimilar development,
market entry, and uptake.
8. Similarly, there are complex
considerations impacting generic drug
market entry. We are interested in the
possible impacts of MMA products on
generic drug development and market
entry.
9. Are there voluntary steps a
manufacturer may take in addition to
the requirements in the DSCSA to
ensure the security of the supply chain
for products imported pursuant to the
guidance?
10. Are there any potential risks
associated with the importation of
products as described in the draft
guidance that could be addressed by a
rulemaking? For example, to what
extent, if any, are there additional
procedures that might better protect
against entities seeking to introduce
counterfeit drugs in the United States?
If so, please be specific about the
potential risk and how it could be
addressed through rulemaking.
III. Paperwork Reduction Act of 1995
FDA has tentatively concluded that
there are no new collections of
information in this draft guidance. This
draft guidance refers to previously
approved collections of information
found in the FD&C Act and FDA
regulations. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). In
accordance with the Paperwork
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Reduction Act, if FDA’s tentative
conclusion changes, prior to publication
of any final guidance document FDA
intends to solicit public comment and
obtain OMB approval for any
information collections recommended
in this guidance that are new or that
would represent material modifications
to those previously approved collections
of information found in FDA regulations
or guidances.
The collections of information in 21
CFR part 314 (new drug applications)
have been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 601
(biologics license applications) have
been approved under OMB control
number 0910–0338; the collections of
information in 21 CFR part 207
(domestic and foreign facility
registration, including assignment of an
NDC) have been approved under OMB
control number 0910–0045; the
collections of information in 21 CFR
part 1 (general enforcement regulations)
have been approved under OMB control
number 0910–0046; the collections of
information in 21 CFR part 201
(labeling) have been approved under
OMB control number 0910–0572; the
collections of information pertaining to
current good manufacturing practice
requirements for finished
pharmaceuticals and combination
products under 21 CFR parts 4, 210,
211, 610, and 680 have been approved
under OMB control numbers 0910–0139
and 0910–0834; and the collections of
information pertaining to suspect
product identification and notification
under section 582 of the FD&C Act have
been approved under OMB control
number 0910–0806.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.
fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: December 11, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019–27475 Filed 12–18–19; 8:45 am]
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70559
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Cancer Institute
Clinical Trials and Translational
Research Advisory Committee.
The meeting will be open to the
public. The open session will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov/).
Name of Committee: National Cancer
Institute Clinical Trials and Translational
Research Advisory Committee.
Date: March 12, 2020.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: Strategic Discussion of NCI’s
Clinical and Translational Research
Programs.
Place: National Institutes of Health,
Building 31, Room 11A01, 31 Center Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sheila A. Prindiville, M.D.,
M.P.H. Director, Coordinating Center for
Clinical Trials, National Institutes of Health,
National Cancer Institute, Coordinating
Center for Clinical Trials, 9609 Medical
Center Drive, Room 6W136, Rockville, MD
20850, 240–276–6173, prindivs@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/ctac/ctac.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: December 17, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–27582 Filed 12–20–19; 8:45 am]
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[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Page 70559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27582]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Meeting
Pursuant to section 10(a) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Cancer
Institute Clinical Trials and Translational Research Advisory
Committee.
The meeting will be open to the public. The open session will be
videocast and can be accessed from the NIH Videocasting and Podcasting
website (https://videocast.nih.gov/).
Name of Committee: National Cancer Institute Clinical Trials and
Translational Research Advisory Committee.
Date: March 12, 2020.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: Strategic Discussion of NCI's Clinical and Translational
Research Programs.
Place: National Institutes of Health, Building 31, Room 11A01,
31 Center Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sheila A. Prindiville, M.D., M.P.H. Director,
Coordinating Center for Clinical Trials, National Institutes of
Health, National Cancer Institute, Coordinating Center for Clinical
Trials, 9609 Medical Center Drive, Room 6W136, Rockville, MD 20850,
240-276-6173, [email protected].
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
Information is also available on the Institute's/Center's home
page: https://deainfo.nci.nih.gov/advisory/ctac/ctac.htm, where an
agenda and any additional information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: December 17, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-27582 Filed 12-20-19; 8:45 am]
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