Proposed Collection; 60-Day Comment Request; Requests for NIH Certificates of Confidentiality, 40426-40427 [2019-17358]
Download as PDF
<![CDATA[
40426
Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
jspears on DSK3GMQ082PROD with NOTICES
CPSC’s regulations list ‘‘special
packaging standards’’ for a wide range
of household products, including most
oral prescription drugs and many
nonprescription drug products (see 16
CFR 1700 for substances requiring
special packaging and the relevant
packaging standards and testing
procedures). It should be noted that
‘‘child-resistant’’ should not be equated
with ‘‘child-proof,’’ because CRP is not
designed to completely eliminate the
possibility of an accidental pediatric
ingestion. It can only impede access to
harmful products and is recognized by
public health experts as only one
component of preventing these events.
There are different ways to make
packaging child-resistant, with the most
common forms being a child-resistant
closure (e.g., a ‘‘safety cap’’) and certain
unit-dose blister packaging (e.g.,
puncture-resistant and peel-push
blisters). FDA advocates that all drugs,
irrespective of the type of packaging, be
stored safely out of reach and sight of
children to further the overall public
health efforts to address this safety
issue.
Because health care professionals and
consumers may not be able to determine
on visual inspection whether the
packaging is child-resistant, a labeling
statement may help to identify this
attribute. Therefore, in this guidance,
we recommend text that may be
appropriate to consider when including
CRP statements in labeling. All of the
stakeholder comments on the draft
guidance were carefully reviewed and,
where appropriate, clarifying edits were
made in the final guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Child-Resistant
Packaging Statements in Drug Product
Labeling.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
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). The collection of
information for submitting labeling in
original and supplemental new drug
applications (NDAs), and abbreviated
new drug applications (ANDAs), and
biologics license applications (BLAs) in
21 CFR 314.50(e) and (l), 314.94(a)(8),
VerDate Sep<11>2014
18:56 Aug 13, 2019
Jkt 247001
314.70, and 314.97, and 21 CFR 601.2
and 601.12 has been approved under
OMB control number 0910–0001 and
0910–0338, respectively. The collection
of information for preparing
prescription drug product labeling
under 21 CFR 201.56 and 201.57 has
been approved under OMB control
number 0910–0572. The collection of
information for Drug Facts labeling
under 21 CFR 201.66 has been approved
under OMB control number 0910–0340.
The collection of information for
Medication Guides has been approved
under OMB control number 0910–0393.
The collection of information for
submitting chemistry, manufacturing,
and controls information in original and
supplemental NDAs, ANDAs, and BLAs
in 21 CFR 314.50(d)(1), 314.94(a)(9),
314.70, and 314.97, and 21 CFR 601.2
and 601.12 has been approved under
OMB control number 0910–0001 and
0910–0338, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.regulations.gov.
Dated: August 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17433 Filed 8–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Requests for NIH Certificates
of Confidentiality
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
Office of Extramural Research (OER), in
the Office of the Director, the National
Institutes of Health (NIH) is
streamlining the electronic system for
the submission and processing of
requests for NIH to issue Certificates of
Confidentiality (CoCs).
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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: Dr. Pamela Reed Kearney,
Division of Human Subjects Research,
OER, NIH, 6705 Rockledge Dr., Building
Rockledge 1, Room 812–C, Bethesda,
MD 20817, or call non-toll-free number
(301) 402–2512, or email your request,
including your address to: NIH-CoCCoordinator@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
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 minimize 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: Electronic
Application for NIH Certificates of
Confidentiality (CoC E-application
System), 0925–0689, exp., date 12/31/
2019 REVISION. Office of Extramural
Research (OER), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This request system provides
one electronic form to be used by all
research organizations that request a
Certificate of Confidentiality (CoC) from
NIH. As described in the authorizing
legislation (Section 301(d) of the Public
Health Service Act, 42 U.S.C. 241(d)),
CoCs are issued by the agencies of
Department of Health and Human
Services (DHHS), including NIH, to
authorize researchers to protect the
privacy of human research subjects by
prohibiting them from releasing names
and identifying characteristics of
DATES:
E:\FR\FM\14AUN1.SGM
14AUN1
40427
Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
research participants to anyone not
connected with the research, except in
limited circumstances specified in the
statute. At NIH, the issuance of CoCs
has been delegated to the NIH OER in
the NIH Office of the Director. NIH
received 529 requests for CoCs from
April 2017 through March 2018 and
expects to receive approximately the
same number of requests in subsequent
years. The NIH has been using an online
CoC system to review requests and issue
CoCs since 2015. The current CoC
request form includes 15 sections of
information collected from research
organizations. The streamlined NIH CoC
electronic system will have seven
sections of structured or short text
fields. The information provided will be
used to determine eligibility for a CoC
and to issue the CoC to the requesting
organization. Eligible requesting
organizations that provide legally
binding affirmations that they will abide
by the terms of the CoC would be issued
a Certificate of Confidentiality. This
system is expected to increase efficiency
and reduce burden for both requestors
and NIH staff who currently process
these requests.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
177.
ESTIMATED ANNUALIZED BURDEN HOURS
CoC
CoC
CoC
CoC
Average time
per response
(in hours)
Total annual
burden hours
Applicants—Private .................................................................................
Applicants—State/local ............................................................................
Applicants—Small business ....................................................................
Applicants—Federal ................................................................................
372
26
53
78
1
1
1
1
20/60
20/60
20/60
20/60
124
9
18
26
Total ..........................................................................................................
529
........................
........................
177
Dated: August 7, 2019.
Lawrence Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–17358 Filed 8–13–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, July 26,
2019, 10:00 a.m. to 5:00 p.m., National
Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892 which was
published in the Federal Register on
July 03, 2019, 84 FR 31878.
The meeting will be held on August
20, 2019 at 9:00 a.m. to 5:00 p.m. The
meeting location remains the same. The
meeting is closed to the public.
Dated: August 8, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–17400 Filed 8–13–19; 8:45 am]
jspears on DSK3GMQ082PROD with NOTICES
Number of responses per
respondent
Number of
respondents
Type of respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
National Institutes of Health
U.S. Customs and Border Protection
National Cancer Institute; Amended
Notice of Meeting
Notice of Issuance of Final
Determination Concerning; Software
Products
Notice is hereby given of a change in
the meeting of the National Cancer
Advisory Board, September 4, 2019,
8:30 a.m. to September 5, 2019, 12:00
p.m., National Institutes of Health,
National Cancer Institute Shady Grove,
9609 Medical Center Drive, Room
TE406 & 408, Rockville, MD 20817
which was published in the Federal
Register on February 11, 2019, 84 FR
3203.
This meeting notice is amended to
change the meeting from a face-to-face
meeting on September 4, 2019, 8:30 a.m.
to September 5, 2019, 12:00 p.m. to a
virtual meeting on September 4, 2019
from 1:00 p.m. to 4:30 p.m. The open
session will be held from 1:00 p.m. to
3:15 p.m. and the closed session will be
held from 3:30 p.m. to 4:30 p.m. The
open session will be videocast and can
be accessed from the NIH Videocasting
and Podcasting website (https://
videocast.nih.gov). The meeting is
partially closed to the public.
AGENCY:
Dated: August 8, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2019–17399 Filed 8–13–19; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
18:56 Aug 13, 2019
Jkt 247001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
This document provides
notice that U.S. Customs and Border
Protection (‘‘CBP’’) has issued a final
determination concerning the country of
origin of CIS Secure Computing, Inc.’s
software products for use on mobile
devices and on servers and other similar
network devices. Based upon the facts
presented, CBP has concluded that the
software products are substantially
transformed in the United States for
purposes of U.S. Government
procurement.
DATES: The final determination was
issued on August 7, 2019. A copy of the
final determination is attached. Any
party-at-interest, as defined in 19 CFR
177.22(d), may seek judicial review of
this final determination no later than
September 13, 2019.
FOR FURTHER INFORMATION CONTACT:
James Kim, Valuation and Special
Programs Branch, Regulations and
Rulings, Office of Trade (202) 325–0158.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that on August 7, 2019,
pursuant to subpart B of Part 177, U.S.
Customs and Border Protection
Regulations (19 CFR part 177, subpart
SUMMARY:
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40426-40427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Requests for NIH
Certificates of Confidentiality
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Office of Extramural Research (OER), in the
Office of the Director, the National Institutes of Health (NIH) is
streamlining the electronic system for the submission and processing of
requests for NIH to issue Certificates of Confidentiality (CoCs).
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: Dr. Pamela
Reed Kearney, Division of Human Subjects Research, OER, NIH, 6705
Rockledge Dr., Building Rockledge 1, Room 812-C, Bethesda, MD 20817, or
call non-toll-free number (301) 402-2512, 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 minimize 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: Electronic Application for NIH
Certificates of Confidentiality (CoC E-application System), 0925-0689,
exp., date 12/31/2019 REVISION. Office of Extramural Research (OER),
National Institutes of Health (NIH).
Need and Use of Information Collection: This request system
provides one electronic form to be used by all research organizations
that request a Certificate of Confidentiality (CoC) from NIH. As
described in the authorizing legislation (Section 301(d) of the Public
Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the agencies
of Department of Health and Human Services (DHHS), including NIH, to
authorize researchers to protect the privacy of human research subjects
by prohibiting them from releasing names and identifying
characteristics of
[[Page 40427]]
research participants to anyone not connected with the research, except
in limited circumstances specified in the statute. At NIH, the issuance
of CoCs has been delegated to the NIH OER in the NIH Office of the
Director. NIH received 529 requests for CoCs from April 2017 through
March 2018 and expects to receive approximately the same number of
requests in subsequent years. The NIH has been using an online CoC
system to review requests and issue CoCs since 2015. The current CoC
request form includes 15 sections of information collected from
research organizations. The streamlined NIH CoC electronic system will
have seven sections of structured or short text fields. The information
provided will be used to determine eligibility for a CoC and to issue
the CoC to the requesting organization. Eligible requesting
organizations that provide legally binding affirmations that they will
abide by the terms of the CoC would be issued a Certificate of
Confidentiality. This system is expected to increase efficiency and
reduce burden for both requestors and NIH staff who currently process
these requests.
OMB approval is requested for three years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 177.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
CoC Applicants--Private......................... 372 1 20/60 124
CoC Applicants--State/local..................... 26 1 20/60 9
CoC Applicants--Small business.................. 53 1 20/60 18
CoC Applicants--Federal......................... 78 1 20/60 26
---------------------------------------------------------------
Total....................................... 529 .............. .............. 177
----------------------------------------------------------------------------------------------------------------
Dated: August 7, 2019.
Lawrence Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-17358 Filed 8-13-19; 8:45 am]
BILLING CODE 4140-01-P
