Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration, 57442-57443 [2019-23268]
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57442
Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Elaine Lippmann, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6238,
Silver Spring, MD 20993, 301–796–
3600; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on ‘‘Drug
Products Labeled as Homeopathic.’’ 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.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23335 Filed 10–24–19; 8:45 am]
BILLING CODE 4164–01–P
I. Background
In the Federal Register on December
20, 2017 (82 FR 60403), FDA announced
the availability of a draft guidance for
FDA staff and industry entitled ‘‘Drug
Products Labeled as Homeopathic.’’
This draft guidance was intended to
describe how FDA intends to prioritize
enforcement and regulatory action with
regard to drug products, including
biological products, labeled as
homeopathic and marketed in the
United States without the required FDA
approval that potentially pose higher
risk to public health.
In response to comments received, we
have revised the draft guidance and are
reissuing it to enable the public to
review and comment before it is
finalized. In particular, we have added
a definition of ‘‘homeopathic drug
product’’ for purposes of the guidance,
added additional explanation of some of
the safety issues that contributed to the
development of the draft guidance, and
clarified the intent to use risk-based
factors to prioritize enforcement and
regulatory actions involving
homeopathic products that are marketed
without required FDA approval. In
addition, the revised draft guidance
removes the statement that the Agency
will withdraw the compliance policy
guide (CPG) simultaneous with the
issuance of the final guidance.
Elsewhere in this Federal Register, FDA
is announcing the withdrawal of CPG
400.400.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
VerDate Sep<11>2014
18:04 Oct 24, 2019
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2683]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Social and Behavioral Research as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
25, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0847. Also
include the FDA docket number found
SUMMARY:
PO 00000
Frm 00061
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in brackets in the heading of this
document.
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:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Data To Support Social and Behavioral
Research as Used by the Food and Drug
Administration
OMB Control Number 0910–0847—
Extension
Understanding patients, consumers,
and healthcare professionals’
perceptions and behaviors plays an
important role in improving FDA’s
regulatory decisionmaking processes
and communications impacting various
stakeholders. The methods used to
achieve these goals include individual
in-depth interviews, general public
focus group interviews, intercept
interviews, self-administered surveys,
gatekeeper surveys, and focus group
interviews. The methods used serve the
narrowly defined need for direct and
informal opinion on a specific topic and
as a qualitative and quantitative
research tool, and have two major
purposes:
1. To obtain information that is useful
for developing variables and measures
for formulating the basic objectives of
social and behavioral research and
2. To assess the potential effectiveness
of FDA communications, behavioral
interventions and other materials in
reaching and successfully
communicating and addressing
behavioral change with their intended
audiences.
FDA will use these methods to test
and refine its ideas and to help develop
communication and behavioral
strategies research, but will generally
conduct further research before making
important decisions such as adopting
new policies and allocating or
redirecting significant resources to
support these policies.
FDA’s Center for Drug Evaluation and
Research, Center for Biologics
Evaluation and Research, Office of the
Commissioner, and any other Centers or
Offices will use this mechanism to test
communications and social and
behavioral methods about regulated
drug products on a variety of subjects
related to consumer, patient, or
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
healthcare professional perceptions,
beliefs, attitudes, behaviors, and use of
drug and biological products and related
materials including, but not limited to,
social and behavioral research, decisionmaking processes, and communication
and behavioral change strategies.
Annually, FDA projects about 45
social and behavioral studies using the
variety of test methods listed in this
document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
In the Federal Register of June 19,
2019 (84 FR 28557), FDA published a
57443
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Interviews/Surveys .............................
1 There
5,040
Average burden
per response
73,584
Fax written comments on the
collection of information by November
25, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0607. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Dated: October 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23268 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–2013–N–0514]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Administrative
Procedures for Clinical Laboratory
Improvement Amendments
Categorization
Food and Drug Administration,
HHS.
ACTION:
14.6
Total annual
responses
0.25 (15 minutes) ....
Total hours
18,396
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 9,198 hours and a
corresponding increase of 36,792
responses due to an increase in grant
funding for universities and others to
perform research for FDA.
AGENCY:
Number of
responses per
respondent
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Administrative Procedures for Clinical
Laboratory Improvement Amendments
of 1988 Categorization—42 CFR 493.17
OMB Control Number 0910–0607—
Extension
FDA’s guidance entitled
‘‘Administrative Procedures for CLIA
Categorization’’1 describes procedures
FDA uses to assign the complexity
category to a device, which affects what
type of Clinical Laboratory
Improvement Amendments of 1988
(CLIA) certificate the laboratory obtains.
Typically, FDA assigns complexity
categorizations to devices at the time of
clearance or approval of the device. In
some cases, however, a manufacturer
may request CLIA categorization even if
FDA is not simultaneously reviewing a
510(k) or premarket approval
application (PMA). One example is
when a manufacturer requests that FDA
assign CLIA categorization to a
previously cleared device that has
changed names since the original CLIA
categorization. Another example is
when a device is exempt from
premarket review. In such cases, the
guidance recommends that
manufacturers provide FDA with a copy
of the package insert for the device and
a cover letter indicating why the
manufacturer is requesting a
categorization (e.g., name change,
exempt from 510(k) review). The
guidance recommends that in the
correspondence to FDA the
manufacturer should identify the
product code and classification as well
as reference to the original 510(k) when
this is available.
In the Federal Register of June 26,
2019 (84 FR 30127), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
1 Available at https://www.fda.gov/media/71065/
download.
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]]>Agencies
[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57442-57443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2683]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Data To Support
Social and Behavioral Research as Used by the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 25, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0847.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Data To Support Social and Behavioral Research as Used by the Food and
Drug Administration
OMB Control Number 0910-0847--Extension
Understanding patients, consumers, and healthcare professionals'
perceptions and behaviors plays an important role in improving FDA's
regulatory decisionmaking processes and communications impacting
various stakeholders. The methods used to achieve these goals include
individual in-depth interviews, general public focus group interviews,
intercept interviews, self-administered surveys, gatekeeper surveys,
and focus group interviews. The methods used serve the narrowly defined
need for direct and informal opinion on a specific topic and as a
qualitative and quantitative research tool, and have two major
purposes:
1. To obtain information that is useful for developing variables
and measures for formulating the basic objectives of social and
behavioral research and
2. To assess the potential effectiveness of FDA communications,
behavioral interventions and other materials in reaching and
successfully communicating and addressing behavioral change with their
intended audiences.
FDA will use these methods to test and refine its ideas and to help
develop communication and behavioral strategies research, but will
generally conduct further research before making important decisions
such as adopting new policies and allocating or redirecting significant
resources to support these policies.
FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the Commissioner, and any other
Centers or Offices will use this mechanism to test communications and
social and behavioral methods about regulated drug products on a
variety of subjects related to consumer, patient, or
[[Page 57443]]
healthcare professional perceptions, beliefs, attitudes, behaviors, and
use of drug and biological products and related materials including,
but not limited to, social and behavioral research, decision-making
processes, and communication and behavioral change strategies.
Annually, FDA projects about 45 social and behavioral studies using
the variety of test methods listed in this document. FDA is requesting
this burden so as not to restrict the Agency's ability to gather
information on public sentiment for its proposals in its regulatory and
communications programs.
In the Federal Register of June 19, 2019 (84 FR 28557), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys..................... 5,040 14.6 73,584 0.25 (15 minutes).................. 18,396
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall increase of 9,198 hours and a corresponding increase of 36,792
responses due to an increase in grant funding for universities and
others to perform research for FDA.
Dated: October 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23268 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P
