Proposed Collection; 60-day Comment Request: A Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NCI's Communication and Education Resources (NCI), 13670-13671 [2019-06735]
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13670
Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Notices
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ANTIVERT (meclizine hydrochloride)
chewable tablets, 25 mg, and tablets,
12.5 mg, 25 mg, and 50 mg, are the
subject of NDA 010721, currently held
by Casper Pharma LLC, and initially
approved on February 14, 1957.
ANTIVERT is indicated for the
treatment of vertigo associated with
diseases affecting the vestibular system.
ANTIVERT (meclizine hydrochloride)
chewable tablets, 25 mg, and tablets,
12.5 mg, 25 mg, and 50 mg, are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Since 2011, the Agency has received
four citizen petitions, submitted under
21 CFR 10.30, requesting that FDA
determine whether one or more dosage
forms and strengths of ANTIVERT were
withdrawn from sale for reasons of
safety or effectiveness.
• InvaGen Pharmaceuticals submitted
a citizen petition dated January 14,
2011, and amendment dated February
24, 2011 (Docket No. FDA–2011–P–
VerDate Sep<11>2014
18:46 Apr 04, 2019
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0047), requesting that the Agency
determine whether ANTIVERT
(meclizine hydrochloride) chewable
tablets, 25 mg, was withdrawn from sale
for reasons of safety or effectiveness.
• Modavar Pharmaceuticals LLC
submitted a citizen petition dated May
4, 2012, (Docket No. FDA–2012–P–
0468) requesting that the Agency
determine whether ANTIVERT
(meclizine hydrochloride) tablets, 12.5
mg and 25 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
• Lupin Pharmaceuticals, Inc.
submitted a citizen petition dated
September 18, 2015 (Docket No. FDA–
2015–P–3400), requesting that the
Agency determine whether ANTIVERT
(meclizine hydrochloride) tablets, 12.5
mg, 25 mg, and 50 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
• Zydus Pharmaceuticals submitted a
citizen petition dated June 14, 2016
(Docket No. FDA–2016–P–1667),
requesting that the Agency determine
whether ANTIVERT (meclizine
hydrochloride) tablets, 12.5 mg and 25
mg, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petitions
and reviewing Agency records, and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ANTIVERT (meclizine
hydrochloride) chewable tablets, 25 mg,
and tablets, 12.5 mg, 25 mg, and 50 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioners
have identified no data or other
information suggesting that these drug
products were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
ANTIVERT (meclizine hydrochloride)
chewable tablets, 25 mg, and tablets,
12.5 mg, 25 mg, and 50 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
post marketing adverse events. We have
found no information that would
indicate that these drug products were
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list ANTIVERT
(meclizine hydrochloride) chewable
tablets, 25 mg, and tablets, 12.5 mg, 25
mg, and 50 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to these drug products. Additional
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ANDAs for these drug products may
also be approved by the Agency as long
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: April 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–06656 Filed 4–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Center for
Scientific Review Advisory Council
(CSRAC) was renewed for an additional
two-year period on March 31, 2019.
It is determined that the CSRAC is in
the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquiries may be directed to Claire
Harris, Acting Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Code 4875), Telephone (301) 496–
2123, or harriscl@mail.nih.gov.
Dated: April 1, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–06615 Filed 4–4–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request: A Generic Submission for
Formative Research, Pretesting and
Customer Satisfaction of NCI’s
Communication and Education
Resources (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
E:\FR\FM\05APN1.SGM
Notice.
05APN1
13671
Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Notices
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health, National
Cancer Institute (NCI) will publish
periodic summaries of propose projects
to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ilene France, Branch Chief,
Office of Communication and Public
Liaison, National Cancer Institute, 9609
Medical Center Drive, Rockville, MD,
20850 or call non-toll-free number (240)
276–7787 or Email your request,
including your address to: nciocpl@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
FOR FURTHER INFORMATION CONTACT:
treatment, the Institute develops a wide
variety of messages and materials.
Testing these messages and materials
assesses their potential effectiveness in
reaching and communicating with their
intended audience while they are still in
the developmental stage and can be
revised. The formative research and
pretesting process thus contributes to
maximizing NCI’s limited dollar
resources for information dissemination
and education. NCI also must ensure the
relevance, utility, and appropriateness
of the many educational programs and
products that the Institute produces.
Customer satisfaction studies help NCI
identify modifications necessary to meet
the needs of NCI’s various target
audiences. Since the previous
submission, there have been 8 approved
sub-studies (and 1 pending) with an
approved request of 1,967 burden hours
over 2.5 years. Approval is requested for
the conduct of multiple studies
annually using such methods as
interviews, focus groups, and various
types of surveys. The content, timing,
and number of respondents to be
included in each sub-study will vary,
depending on the nature of the message/
material/program being assessed, the
methodology selected, and the target
audiences.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
7,200.
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’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 minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: A Generic
Submission for Formative Research,
Pretesting and Customer Satisfaction of
NCI’s Communication and Education
Resources (NCI), 0925–0046, Expiration
Date 07/31/2019, REVISION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This information collection
request is to approve the Generic
Submission for Formative Research,
Pretesting and Customer Satisfaction of
NCI’s Communication and Education
Resources (NCI) for three years. As part
of NCI’s mandate from Congress to
disseminate information on cancer
research, detection, prevention, and
ESTIMATED ANNUALIZED BURDEN HOURS
Average time
per response
(in hours)
Type of
respondents
Focus Groups, Individual In-Depth Interviews, Brief Interviews, Surveys,
Website Usability Testing.
Focus Groups, Individual In-Depth Interviews, Brief Interviews, Surveys,
Website Usability Testing.
Individuals (General Public) ......
18,000
1
12/60
3,600
Individuals (Health Care Professionals).
18,000
1
12/60
3,600
Total ..................................................
....................................................
36,000
36,000
........................
7,200
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–06735 Filed 4–4–19; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
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Number of
respondents
Number of
responses per
respondent
Form name
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
VerDate Sep<11>2014
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Total annual
burden hours
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Center without Walls for
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]]>Agencies
[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Notices]
[Pages 13670-13671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06735]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment Request: A Generic Submission
for Formative Research, Pretesting and Customer Satisfaction of NCI's
Communication and Education Resources (NCI)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 13671]]
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health, National Cancer
Institute (NCI) will publish periodic summaries of propose projects to
be submitted to the Office of Management and Budget (OMB) for review
and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Ilene
France, Branch Chief, Office of Communication and Public Liaison,
National Cancer Institute, 9609 Medical Center Drive, Rockville, MD,
20850 or call non-toll-free number (240) 276-7787 or Email your
request, including your address to: [email protected]. Formal
requests for additional plans and instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency'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 minimizes the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: A Generic Submission for Formative
Research, Pretesting and Customer Satisfaction of NCI's Communication
and Education Resources (NCI), 0925-0046, Expiration Date 07/31/2019,
REVISION, National Cancer Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information Collection: This information collection
request is to approve the Generic Submission for Formative Research,
Pretesting and Customer Satisfaction of NCI's Communication and
Education Resources (NCI) for three years. As part of NCI's mandate
from Congress to disseminate information on cancer research, detection,
prevention, and treatment, the Institute develops a wide variety of
messages and materials. Testing these messages and materials assesses
their potential effectiveness in reaching and communicating with their
intended audience while they are still in the developmental stage and
can be revised. The formative research and pretesting process thus
contributes to maximizing NCI's limited dollar resources for
information dissemination and education. NCI also must ensure the
relevance, utility, and appropriateness of the many educational
programs and products that the Institute produces. Customer
satisfaction studies help NCI identify modifications necessary to meet
the needs of NCI's various target audiences. Since the previous
submission, there have been 8 approved sub-studies (and 1 pending) with
an approved request of 1,967 burden hours over 2.5 years. Approval is
requested for the conduct of multiple studies annually using such
methods as interviews, focus groups, and various types of surveys. The
content, timing, and number of respondents to be included in each sub-
study will vary, depending on the nature of the message/material/
program being assessed, the methodology selected, and the target
audiences.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 7,200.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Type of respondents Number of responses per per response Total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Groups, Individual In-Depth Interviews, Individuals (General Public)........... 18,000 1 12/60 3,600
Brief Interviews, Surveys, Website Usability
Testing.
Focus Groups, Individual In-Depth Interviews, Individuals (Health Care Professionals) 18,000 1 12/60 3,600
Brief Interviews, Surveys, Website Usability
Testing.
---------------------------------------------------------------
Total...................................... ....................................... 36,000 36,000 .............. 7,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2019-06735 Filed 4-4-19; 8:45 am]
BILLING CODE 4140-01-P
