Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs; Revised Draft Guidance for Industry; Availability, 6998-7000 [2015-02527]
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6998
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
number 0910–0485; the collections of
information in 21 CFR part 803 are
approved under OMB control numbers
0910–0437 and 0910–0291; the
collections of information in 21 CFR
part 806 are approved under OMB
control number 0910–0359; the
collections of information in 21 CFR
part 807 subparts B and C are approved
under OMB control number 0910–0625;
the collections of information in 21 CFR
part 807 subpart E are approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 812 are approved under OMB
control number 0910–0078; the
collections of information in 21 CFR
part 814 subparts A through E are
approved under OMB control number
0910–0231; the collections of
information in 21 CFR part 820 are
approved under OMB control number
0910–0073; and the collections of
information regarding section 513(g) of
the FD&C Act (21 U.S.C. 360c(g)) are
approved under OMB control number
0910–0705.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: February 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02573 Filed 2–6–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2004–D–0500 (Formerly
Docket No. 2004D–0042)]
Brief Summary and Adequate
Directions for Use: Disclosing Risk
Information in Consumer-Directed
Print Advertisements and Promotional
Labeling for Human Prescription
Drugs; Revised Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:39 Feb 06, 2015
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Notice of availability;
withdrawal.
ACTION:
FOR FURTHER INFORMATION CONTACT:
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Brief Summary
and Adequate Directions for Use:
Disclosing Risk Information in
Consumer-Directed Print
Advertisements and Promotional
Labeling for Human Prescription
Drugs.’’ This revised draft guidance,
when finalized, will assist
manufacturers, packers, and distributors
(firms) of human prescription drugs and
biologics with meeting the brief
summary requirement for prescription
drug advertising and the requirement
that adequate directions for use be
included with promotional labeling for
prescription drugs when print materials
are directed toward consumers. FDA is
also announcing the withdrawal of the
draft guidance for industry entitled
‘‘Brief Summary: Disclosing Risk
Information in Consumer-Directed Print
Advertisements.’’
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this
revised draft guidance before it begins
work on the final version of the
guidance, submit either electronic or
written comments on the revised draft
guidance by May 11, 2015. Submit
either electronic or written comments
on the proposed collection of
information by April 10, 2015.
DATES:
Submit written requests for
single copies of the revised draft
guidance to the Division of Drug
Information, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring,
MD 20993–0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, 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 revised draft guidance
document.
Submit electronic comments on the
revised draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
ADDRESSES:
PO 00000
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Sfmt 4703
Regarding human prescription drugs:
Julie Chronis, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993–0002, 301–796–1200.
Regarding human prescription
biological products: Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Brief Summary and Adequate
Directions for Use: Disclosing Risk
Information in Consumer-Directed Print
Advertisements and Promotional
Labeling for Human Prescription
Drugs.’’ This revised draft guidance
updates prior FDA policy and describes
the Agency’s current thinking regarding
the brief summary requirement for
consumer-directed print prescription
drug advertisements. Specifically, the
revised draft guidance includes
recommendations for developing a
consumer brief summary and notes that,
so long as firms include appropriate
information in a print advertisement as
outlined in the revised draft guidance,
FDA does not intend to object for a
failure to include certain other
information.
Additionally, this revised draft
guidance provides new
recommendations regarding the
adequate directions for use requirement
for consumer-directed print promotional
labeling for prescription drug products.
Although the requirement in 21 CFR
201.100(d) for firms to provide adequate
information for use is generally fulfilled
by providing the full FDA-approved
package insert (PI), this revised draft
guidance provides that, in exercising its
enforcement discretion, FDA does not
intend to object for failure to include the
full PI with consumer-directed print
promotional labeling pieces if firms
include the appropriate information as
outlined in the revised draft guidance,
i.e., the same information in the
consumer brief summary. This
recommendation is designed to
standardize the information consumers
receive in print prescription drug
product advertisements and
promotional labeling and to make
information more understandable to
consumers.
FDA issued a draft guidance in the
Federal Register of February 10, 2004
(69 FR 6308), entitled ‘‘Brief Summary:
E:\FR\FM\09FEN1.SGM
09FEN1
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
Disclosing Risk Information in
Consumer-Directed Print
Advertisements.’’ FDA requested
comments on whether the draft
guidance provided sufficient guidance
on the content of the consumer brief
summary and also requested research
results on potential formats for the
consumer brief summary. Comments,
suggestions, and research were
submitted to Docket No. 2004D–0042
and were carefully analyzed and
considered before developing this
revised draft guidance.
This revised draft guidance
incorporates information from recent
social science research, clarifies the risk
information that should be included in
the consumer brief summary, and
recommends several formatting options
for this information. The revised draft
guidance also recommends the use of
consumer-friendly language and visual
techniques to improve accessibility for
consumers. Additionally, this revised
draft guidance recommends that firms
not disseminate the full PI to fulfill the
requirements in § 201.100(d) for
consumer-directed print promotional
labeling for prescription drugs. Rather,
the revised draft guidance recommends
that firms provide the same content and
format created for the consumer brief
summary. FDA is issuing this revised
guidance as a draft to allow for public
comment on the recommendations.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulations (21 CFR
10.115). The revised draft guidance,
when finalized, will represent FDA’s
current thinking on the brief summary
and adequate directions for use
requirements. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
This revised draft guidance also refers to
previously approved collection of
information found in FDA regulations.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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 collected; and (4) ways to
minimize the burden of information
collected on the respondents, including
through the use of automated collection
techniques, when appropriate, and other
forms of information technology.
Title: Brief Summary and Adequate
Directions for Use: Disclosing Risk
Information in Consumer-Directed Print
Advertisements and Promotional
Labeling for Human Prescription Drugs.
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors (firms) of prescription
human drug products, including
biological products.
Burden Estimate: The revised draft
guidance pertains to the brief summary
requirement for prescription drug
advertising and the requirement that
adequate directions for use be included
with promotional labeling for human
prescription drugs when print materials
are directed toward consumers.
6999
The revised draft guidance, in part,
explains FDA’s current policy position
that FDA does not intend to object for
failure to include the entire PI to fulfill
the requirements of § 201.100(d) for
promotional labeling pieces directed
toward consumers, if firms instead
provide information on the most serious
and the most common risks associated
with the product, while omitting less
important information. Specifically,
FDA recommends that any Boxed
Warning, all Contraindications, certain
information regarding Warnings and
Precautions (i.e., the most clinically
significant information from the
Warnings and Precautions section of the
PI, information that would affect a
decision to prescribe or take a drug,
monitoring or laboratory tests that may
be needed, special precautions not set
forth in other parts of the PI, and
measures that can be taken to prevent or
mitigate harm), and the most frequently
occurring Adverse Reactions should be
included.
Furthermore, FDA recommends that
information should include the
indication for the use being promoted.
Information regarding patient directives
(such as ‘‘discuss with your health care
provider any pre-existing conditions’’ or
‘‘tell your health care provider if you are
taking any medications’’) should also be
included. Other types of information
may be included if relevant to the drug
or specific indication referred to in the
promotional material(s). A statement
should be included that more
comprehensive information can be
obtained from various sources,
including the firm.
Thus, the revised draft guidance
recommends that firms disclose certain
information to others in place of the PI
to fulfill the requirements in
§ 201.100(d). This ‘‘third-party
disclosure’’ constitutes a ‘‘collection of
information’’ under the PRA.
FDA estimates that approximately 400
firms disseminate 24,000 consumerdirected print promotional labeling
pieces annually. FDA estimates that it
will take firms approximately 10 hours
to compile and draft the information
needed to provide the information
recommended in the revised draft
guidance.
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Adequate information for use: disclosing risk
information in consumer-directed promotional
labeling
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Hours per
disclosure
Total hours
Disclosures Related to Adequate Information
for Use (§ 201.100(d)) ..................................
400
60
24,000
10
240,000
There are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
This revised draft guidance also refers
to previously approved collections of
information found in FDA regulations
with respect to the brief summary
requirement. These collections of
information are subject to review by
OMB under the PRA. The collection of
information in 21 CFR 202.1 has been
approved under OMB control number
0910–0686.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Comments
AGENCY:
In addition to general comments, FDA
specifically requests comments on the
following issues:
• In the revised draft guidance, FDA
provides recommendations regarding
the content and format of the consumer
brief summary. Is this the most useful
information for consumers to use in
determining whether to take a
medication or seek more information
about a product, and if not, what
information would be more useful?
• FDA is also interested in relevant
research that has been conducted or
alternative formats that were developed
after we received comments on the 2004
draft guidance.
• In the revised draft guidance, FDA
suggests that the adequate directions for
use requirement be fulfilled by
providing the consumer brief summary
rather than the full PI for the product.
FDA seeks comments regarding this
recommendation.
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
Dated: February 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02527 Filed 2–6–15; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 235001
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Pulmonary-Allergy
Drugs Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: PulmonaryAllergy Drugs Advisory Committee and
the Drug Safety and Risk Management
Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 19, 2015, from 8 a.m. to
5 p.m.
Location: Holiday Inn Gaithersburg
Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel
telephone number is 301–948–8900.
Contact Person: Cindy Hong, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533,
PADAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://www.fda.
gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate
advisory committee meeting link, or call
the advisory committee information line
to learn about possible modifications
before coming to the meeting.
Agenda: The committees will discuss
supplemental new drug application
204275–S001, for fluticasone furoate
and vilanterol inhalation powder
(tradename Breo Ellipta) submitted by
GlaxoSmithKline for the once daily
maintenance treatment of asthma in
patients 12 years of age and older. The
discussion will include efficacy data,
but the focus of the meeting will be
safety, including the adequacy of the
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safety database to support approval, and
whether a large safety trial to evaluate
serious asthma outcomes is
recommended.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 5, 2015. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before February
25, 2015. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by February 26, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Cindy Hong
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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]]>Agencies
[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 6998-7000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-D-0500 (Formerly Docket No. 2004D-0042)]
Brief Summary and Adequate Directions for Use: Disclosing Risk
Information in Consumer-Directed Print Advertisements and Promotional
Labeling for Human Prescription Drugs; Revised Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry entitled ``Brief
Summary and Adequate Directions for Use: Disclosing Risk Information in
Consumer-Directed Print Advertisements and Promotional Labeling for
Human Prescription Drugs.'' This revised draft guidance, when
finalized, will assist manufacturers, packers, and distributors (firms)
of human prescription drugs and biologics with meeting the brief
summary requirement for prescription drug advertising and the
requirement that adequate directions for use be included with
promotional labeling for prescription drugs when print materials are
directed toward consumers. FDA is also announcing the withdrawal of the
draft guidance for industry entitled ``Brief Summary: Disclosing Risk
Information in Consumer-Directed Print Advertisements.''
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this revised draft guidance before it begins work on the final version
of the guidance, submit either electronic or written comments on the
revised draft guidance by May 11, 2015. Submit either electronic or
written comments on the proposed collection of information by April 10,
2015.
ADDRESSES: Submit written requests for single copies of the revised
draft guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, 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 revised draft guidance document.
Submit electronic comments on the revised draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs:
Julie Chronis, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD
20993-0002, 301-796-1200. Regarding human prescription biological
products: Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Brief Summary and Adequate Directions for Use:
Disclosing Risk Information in Consumer-Directed Print Advertisements
and Promotional Labeling for Human Prescription Drugs.'' This revised
draft guidance updates prior FDA policy and describes the Agency's
current thinking regarding the brief summary requirement for consumer-
directed print prescription drug advertisements. Specifically, the
revised draft guidance includes recommendations for developing a
consumer brief summary and notes that, so long as firms include
appropriate information in a print advertisement as outlined in the
revised draft guidance, FDA does not intend to object for a failure to
include certain other information.
Additionally, this revised draft guidance provides new
recommendations regarding the adequate directions for use requirement
for consumer-directed print promotional labeling for prescription drug
products. Although the requirement in 21 CFR 201.100(d) for firms to
provide adequate information for use is generally fulfilled by
providing the full FDA-approved package insert (PI), this revised draft
guidance provides that, in exercising its enforcement discretion, FDA
does not intend to object for failure to include the full PI with
consumer-directed print promotional labeling pieces if firms include
the appropriate information as outlined in the revised draft guidance,
i.e., the same information in the consumer brief summary. This
recommendation is designed to standardize the information consumers
receive in print prescription drug product advertisements and
promotional labeling and to make information more understandable to
consumers.
FDA issued a draft guidance in the Federal Register of February 10,
2004 (69 FR 6308), entitled ``Brief Summary:
[[Page 6999]]
Disclosing Risk Information in Consumer-Directed Print
Advertisements.'' FDA requested comments on whether the draft guidance
provided sufficient guidance on the content of the consumer brief
summary and also requested research results on potential formats for
the consumer brief summary. Comments, suggestions, and research were
submitted to Docket No. 2004D-0042 and were carefully analyzed and
considered before developing this revised draft guidance.
This revised draft guidance incorporates information from recent
social science research, clarifies the risk information that should be
included in the consumer brief summary, and recommends several
formatting options for this information. The revised draft guidance
also recommends the use of consumer-friendly language and visual
techniques to improve accessibility for consumers. Additionally, this
revised draft guidance recommends that firms not disseminate the full
PI to fulfill the requirements in Sec. 201.100(d) for consumer-
directed print promotional labeling for prescription drugs. Rather, the
revised draft guidance recommends that firms provide the same content
and format created for the consumer brief summary. FDA is issuing this
revised guidance as a draft to allow for public comment on the
recommendations.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulations (21 CFR 10.115). The revised draft
guidance, when finalized, will represent FDA's current thinking on the
brief summary and adequate directions for use requirements. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.
II. The Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document. This
revised draft guidance also refers to previously approved collection of
information found in FDA regulations.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA'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 collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Brief Summary and Adequate Directions for Use: Disclosing
Risk Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Human Prescription Drugs.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors (firms) of
prescription human drug products, including biological products.
Burden Estimate: The revised draft guidance pertains to the brief
summary requirement for prescription drug advertising and the
requirement that adequate directions for use be included with
promotional labeling for human prescription drugs when print materials
are directed toward consumers.
The revised draft guidance, in part, explains FDA's current policy
position that FDA does not intend to object for failure to include the
entire PI to fulfill the requirements of Sec. 201.100(d) for
promotional labeling pieces directed toward consumers, if firms instead
provide information on the most serious and the most common risks
associated with the product, while omitting less important information.
Specifically, FDA recommends that any Boxed Warning, all
Contraindications, certain information regarding Warnings and
Precautions (i.e., the most clinically significant information from the
Warnings and Precautions section of the PI, information that would
affect a decision to prescribe or take a drug, monitoring or laboratory
tests that may be needed, special precautions not set forth in other
parts of the PI, and measures that can be taken to prevent or mitigate
harm), and the most frequently occurring Adverse Reactions should be
included.
Furthermore, FDA recommends that information should include the
indication for the use being promoted. Information regarding patient
directives (such as ``discuss with your health care provider any pre-
existing conditions'' or ``tell your health care provider if you are
taking any medications'') should also be included. Other types of
information may be included if relevant to the drug or specific
indication referred to in the promotional material(s). A statement
should be included that more comprehensive information can be obtained
from various sources, including the firm.
Thus, the revised draft guidance recommends that firms disclose
certain information to others in place of the PI to fulfill the
requirements in Sec. 201.100(d). This ``third-party disclosure''
constitutes a ``collection of information'' under the PRA.
FDA estimates that approximately 400 firms disseminate 24,000
consumer-directed print promotional labeling pieces annually. FDA
estimates that it will take firms approximately 10 hours to compile and
draft the information needed to provide the information recommended in
the revised draft guidance.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Adequate information for use: disclosing risk information Number of disclosures per Total annual Hours per Total hours
in consumer-directed promotional labeling respondents respondent disclosures disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosures Related to Adequate Information for Use (Sec. 400 60 24,000 10 240,000
201.100(d))...........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 7000]]
This revised draft guidance also refers to previously approved
collections of information found in FDA regulations with respect to the
brief summary requirement. These collections of information are subject
to review by OMB under the PRA. The collection of information in 21 CFR
202.1 has been approved under OMB control number 0910-0686.
III. Comments
In addition to general comments, FDA specifically requests comments
on the following issues:
In the revised draft guidance, FDA provides
recommendations regarding the content and format of the consumer brief
summary. Is this the most useful information for consumers to use in
determining whether to take a medication or seek more information about
a product, and if not, what information would be more useful?
FDA is also interested in relevant research that has been
conducted or alternative formats that were developed after we received
comments on the 2004 draft guidance.
In the revised draft guidance, FDA suggests that the
adequate directions for use requirement be fulfilled by providing the
consumer brief summary rather than the full PI for the product. FDA
seeks comments regarding this recommendation.
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: February 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02527 Filed 2-6-15; 8:45 am]
BILLING CODE 4164-01-P
