Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs; Revised Draft Guidance for Industry (Revision 2); Availability, 46990-46993 [2015-19244]
Download as PDF
46990
Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Notices
mailed to consumers) × $16.56 per
hour.8]
As elaborated on above, staff
estimates that a total of 14,560 labor
hours will be needed to negotiate or
renegotiate outsourced service contracts
annually (or as conditions otherwise
change) to increase internet (8,320
hours) and telephone (6,240 hours)
capacity requirements for internet web
services and the automated telephone
call center. This will result in
approximately $953,971 per year in
labor costs. [14,560 hours × $65.52 per
hour 9]
Thus, estimated cumulative labor will
costs are $7,276,430.
G. Capital/Non-Labor Costs
As in the previous PRA clearance
analysis, FTC staff believes it is likely
that consumer reporting agencies will
use third-party contractors (instead of
their own employees) to increase the
capacity of their systems. Because of the
way these contracts are typically
established, these costs will likely be
incurred on a continuing basis, and will
be calculated based on the number of
requests handled by the systems. Staff
estimates that the total annual amount
to be paid for services delivered under
these contracts is $11,931,500.10
H. Net Burden for FTC, After 50:50 Split
After halving the updated estimates to
split the PRA burden with the CFPB
regarding the Rule, the FTC’s burden
totals are 198,176 hours, $3,638,215 in
associated labor costs, and $5,965,750 in
non-labor/capital costs.
III. Request for Comment
tkelley on DSK3SPTVN1PROD with NOTICES
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before October 5, 2015. Write ‘‘Subpart
N of Regulation V, PRA Comment,
P125403’’ on your comment. Your
comment—including your name and
your state—will be placed on the public
record of this proceeding, including to
the extent practicable, on the public
Commission Web site, at https://
www.ftc.gov/os/publiccomments.shtm.
As a matter of discretion, the
Commission tries to remove individuals’
home contact information from
8 See Occupational Employment and Wages—
May 2014, Table 1, available at https://www.bls.gov/
news.release/ocwage.nr0.htm (Office and
administrative support workers, general).
9 See supra notes 4 and 5.
10 This consists of an estimated $7,913,500 for
automated telephone cost ($1.33 per request × 5.95
million requests) and an estimated $4,018,000
($0.14 per request × 28.7 million requests) for
Internet web service cost. Per unit cost estimates are
based on staff’s knowledge of the industry.
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comments before placing them on the
Commission Web site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’s Social
Security number, date of birth, driver’s
license number or other state
identification number or foreign country
equivalent, passport number, financial
account number, or credit or debit card
number. You are also solely responsible
for making sure that your comment does
not include any sensitive health
information, like medical records or
other individually identifiable health
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which is . . .
privileged or confidential’’ as provided
in section 6(f) of the FTC Act 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR
4.10(a)(2). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c).11 Your
comment will be kept confidential only
if the FTC General Counsel grants your
request in accordance with the law and
the public interest.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
regulationVsubpartNpra, by following
the instructions on the web-based form.
If this Notice appears at https://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘Subpart N of Regulation V, PRA
Comment, P125403’’ on your comment
and on the envelope, and mail or deliver
it to the following address: Federal
Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street, SW. 5th Floor, Suite 5610
(Annex J), Washington, DC 20024. If
possible, submit your paper comment to
11 In particular, the written request for
confidential treatment that accompanies the
comment must include the factual and legal basis
for the request, and must identify the specific
portions of the comment to be withheld from the
public record. See FTC Rule 4.9(c), 16 CFR 4.9(c).
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the Commission by courier or overnight
service.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before October 5, 2015. For information
on the Commission’s privacy policy,
including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/ftc/
privacy.htm.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2015–19378 Filed 8–5–15; 8:45 am]
BILLING CODE 6750–01–P
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 Prescription Drugs;
Revised Draft Guidance for Industry
(Revision 2); Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
reissuance of a revised draft guidance
for industry (Revision 2) entitled ‘‘Brief
Summary and Adequate Directions for
Use: Disclosing Risk Information in
Consumer-Directed Print
Advertisements and Promotional
Labeling for Prescription Drugs.’’ We are
reissuing the revised draft guidance to
incorporate animal prescription drugs.
This reissued revised draft guidance,
when finalized, will assist
manufacturers, packers, and distributors
(firms) of human prescription drugs,
including biologics, and animal
prescription drugs, 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.
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
reissued revised draft guidance before it
SUMMARY:
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tkelley on DSK3SPTVN1PROD with NOTICES
begins work on the final version of the
guidance, submit either electronic or
written comments on the reissued
revised draft guidance by October 5,
2015. Submit either electronic or
written comments on the proposed
collection of information by October 5,
2015.
ADDRESSES: Submit written requests for
single copies of the reissued revised
draft guidance to the Division of Drug
Information, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10001 New Hampshire
Ave. Hillandale Building, 4th Floor,
Silver Spring, MD 20993–0002; 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; or to the
Policy and Regulations Staff (HFV–6),
Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the revised draft
guidance document.
Submit electronic comments on the
reissued 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.
Regarding animal prescription drugs:
Thomas Moskal, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.
Rockville, MD 20855–2792, 240–402–
6251.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the reissuance 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 Prescription Drugs.’’ We are
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reissuing the revised draft guidance to
incorporate animal prescription drugs;
there are no other revisions to the
revised draft guidance for industry
issued February 9, 2015 (80 FR 6998).
As stated previously, the 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, the 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) and 21 CFR 201.105(d) for
firms to provide adequate information
for use is generally fulfilled by
providing the full FDA-approved
package insert (PI), the 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:
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 the
revised draft guidance.
FDA issued the revised draft guidance
in the Federal Register of February 9,
2015, giving interested parties an
opportunity to submit comments by
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46991
May 11, 2015. We are reissuing the
revised draft guidance to incorporate
animal prescription drugs; there are no
other revisions to the revised draft
guidance issued February 2015.
The 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, the 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 the revised
guidance as a draft to allow for public
comment on the recommendations.
The reissued revised draft guidance is
being issued consistent with FDA’s good
guidance practices regulations (21 CFR
10.115). The reissued 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.
The revised draft guidance also refers to
previously approved collection of
information found in FDA regulations.
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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Notices
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 Prescription Drugs.
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors (firms) of human and
animal prescription drug products,
including biological products for use in
humans.
Burden Estimate: The reissued 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 and animal prescription drugs
when print materials are directed
toward consumers.
The reissued 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) and 201.105(d)(1) 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 reissued revised draft
guidance recommends that firms
disclose certain information to others in
place of the PI to fulfill the requirements
in §§ 201.100(d) and 201.105(d). This
‘‘third-party disclosure’’ constitutes a
‘‘collection of information’’ under the
PRA.
FDA estimates that approximately 400
firms subject to § 201.100(d)
disseminate 24,000 consumer-directed
print promotional labeling pieces
annually. FDA estimates that
approximately 40 firms subject to
§ 201.105(d) disseminate 2,000
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. Please note that
the requirements related to print
advertising pieces and the associated
burden is already accounted for under
the requirements under 21 CFR 202.1
and its approved information collection
OMB control number 0910–0686 and,
therefore, is not included in the burden
estimate reported in table 1.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Adequate information for use: Disclosing risk information
in consumer-directed promotional labeling
Number of
respondents
Disclosures Related to Adequate Information for Use
(§ 201.100(d)) ...................................................................
Disclosures Related to Adequate Information for Use
(§ 201.105(d)) ...................................................................
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1 There
Number of
disclosures
per respondent
Total annual
disclosures
Hours per
disclosure
Total hours
400
60
24,000
10
240,000
40
50
2,000
10
20,000
are no capital costs or operating and maintenance costs associated with this collection of information.
This reissued revised draft guidance
also refers to previously approved
collections of information found in FDA
regulations with respect to the brief
summary requirement for print
advertisements. These collections of
information are subject to review by
OMB under the PRA. The collection of
information in § 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:
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• 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
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providing the consumer brief summary
rather than the full PI for the product.
FDA seeks comments regarding this
recommendation.
Persons who commented on the
version of the revised draft guidance
issued in February 2015 do not need to
resubmit their comments. When
finalizing the revised draft guidance, we
will review comments received on this
reissued version, as well as the version
issued February 2015.
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
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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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm, or
https://www.regulations.gov.
Dated: July 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–19244 Filed 8–5–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Program Expansion for the National
Center for Medical Home
Implementation Cooperative
Agreement at the American Academy
of Pediatrics
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Single-Case Deviation
from Competition Requirement for
Program Expansion for the National
Center for Medical Home
Implementation Cooperative Agreement
at the American Academy of Pediatrics,
Grant Number U43MC09134.
AGENCY:
HRSA announces its intent to
award a program expansion supplement
in the amount of $300,000 for the
National Center for Medical Home
Implementation (NCMHI) cooperative
agreement. The purpose of the NCMHI
cooperative agreement, as stated in the
funding opportunity announcement, is
to: (1) Support a national resource and
technical assistance effort to implement
and spread the medical home model to
all children and youth, particularly
children with special health care needs
(CSHCN), children who are vulnerable
and/or medically underserved, and
pediatric populations served by state
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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public health programs, MCHB, and
HRSA; and ( ) support activities of the
Healthy Tomorrows Partnership for
Children Program (HTPCP) grantees to
improve children’s health through
innovative community-based efforts,
and community and statewide
partnerships among professionals in
health, education, social services,
government, and business. The purpose
of this notice is to award supplemental
funds to develop the Rural IMPACT
project to support activities related to
child health in rural and underserved
communities by the American Academy
of Pediatrics, the cooperative agreement
awardee who serves as the NCMHI,
during the budget period of July 1, 2015,
to June 30, 2016. The NCMHI is
authorized by the Social Security Act,
Title V, Sections 501(a)(1)(D) and
501(a)(2)), (42 U.S.C. 701).
The NCHMI is a national resource to
implement and spread the medical
home model to all children and youth,
particularly children with special health
care needs and children who are
vulnerable and/or medically
underserved. The NCMHI supports
activities of the Health Tomorrows
Partnership for Children Program
grantees to improve children’s health
through innovative community-based
efforts, and community and statewide
partnerships among professionals in
health, education, social services,
government, and business.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: The
American Academy of Pediatrics.
Amount of the Non-Competitive
Award: $300,000.
CFDA Number: 93.110.
Current Project Period: July 01, 2008–
June 30, 2018.
Period of Supplemental Funding: July
1, 2015–June 30, 2016.
Authority: Social Security Act, Title
V, sections 501(a)(1)(D) and 501(a)(2),
(42 U.S.C. 701).
Justification: The White House Rural
Council is leading a Rural Child Poverty
Initiative, the Rural IMPACT Project, to
support improved well-being and
upward economic mobility of children
in rural and tribal communities. In
collaboration with the White House
Rural Council, HRSA, and the
Administration for Children and
Families, each using its own authority,
used fiscal year (FY) 2015 funds to
support a cohort of 10 rural and Tribal
communities to provide two-generation,
bundled services to children and
families in need. Utilizing the twogeneration approach, the communities
will promote problem solving at the
community level by encouraging
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46993
pediatric clinicians’ participation and
public-private partnership, such as the
Early Childhood Comprehensive
Systems Initiative, Project Launch, and
private sector support for improved
collaboration and coordination of and
access to mental, oral, and physical
health and non-clinical resources (e.g.
home visiting, early care and education
settings such as child care and Head
Start, early intervention, child welfare,
education) at the community level for
children, youth, and their families.
In 2013, following objective review of
its application, HRSA awarded to the
American Academy of Pediatrics (AAP)
cooperative agreement funding for the
NCMHI. If approved, this would be the
first project expansion supplement for
this project.
Through the NCMHI, the AAP is
working to link key state and
community programs, such as Title V,
school-based health centers, Head Start,
and Early Intervention, which are
critical, natural access points for
building and strengthening integrated
service delivery systems for women,
children, and their families. Working
with the Healthy Tomorrows
Partnership for Children Program
grantees and the AAP Council on
Community Pediatrics Rural Health
Special Interest Group, the NCMHI
supports activities that promote access
to quality, patient/family-centered and
culturally effective services for children,
youth and their families, particularly in
rural and underserved communities.
The proposed Rural IMPACT Project
activities align with the current project
plan, as the NCMHI advances system
changes and new initiatives at the
community, state, and national levels,
building on community partnerships to
support family-centered medical home
implementation for all children and
youth, particularly those
underrepresented and from diverse
communities (Goal 3). The AAP,
working with MCHB, would establish
an expert workgroup and operational
structure to guide the initiative; develop
and issue a solicitation and scoring
process and conduct a review of
applications to make recommendations
for participating communities; develop
a quality improvement package; identify
systems-level measures to monitor
process and progress of individual
communities and the initiative as a
whole, and provide structured technical
assistance to the selected communities.
FOR FURTHER INFORMATION CONTACT:
Marie Y. Mann, MD, MPH, FAAP,
Division of Services for Children with
Special Health Needs, Maternal and
Child Health Bureau, Health Resources
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Agencies
[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Notices]
[Pages 46990-46993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19244]
=======================================================================
-----------------------------------------------------------------------
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 Prescription Drugs; Revised Draft Guidance for Industry
(Revision 2); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
reissuance of a revised draft guidance for industry (Revision 2)
entitled ``Brief Summary and Adequate Directions for Use: Disclosing
Risk Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Prescription Drugs.'' We are reissuing the
revised draft guidance to incorporate animal prescription drugs. This
reissued revised draft guidance, when finalized, will assist
manufacturers, packers, and distributors (firms) of human prescription
drugs, including biologics, and animal prescription drugs, 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.
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 reissued revised draft guidance before it
[[Page 46991]]
begins work on the final version of the guidance, submit either
electronic or written comments on the reissued revised draft guidance
by October 5, 2015. Submit either electronic or written comments on the
proposed collection of information by October 5, 2015.
ADDRESSES: Submit written requests for single copies of the reissued
revised draft guidance to the Division of Drug Information, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave. Hillandale Building, 4th Floor, Silver Spring, MD 20993-
0002; 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; or to the Policy and Regulations Staff (HFV-6), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revised draft guidance
document.
Submit electronic comments on the reissued 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. Regarding animal
prescription drugs: Thomas Moskal, Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl. Rockville, MD 20855-2792,
240-402-6251.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the reissuance 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 Prescription Drugs.'' We are reissuing the
revised draft guidance to incorporate animal prescription drugs; there
are no other revisions to the revised draft guidance for industry
issued February 9, 2015 (80 FR 6998).
As stated previously, the 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, the 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) and 21 CFR
201.105(d) for firms to provide adequate information for use is
generally fulfilled by providing the full FDA-approved package insert
(PI), the 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: 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 the revised
draft guidance.
FDA issued the revised draft guidance in the Federal Register of
February 9, 2015, giving interested parties an opportunity to submit
comments by May 11, 2015. We are reissuing the revised draft guidance
to incorporate animal prescription drugs; there are no other revisions
to the revised draft guidance issued February 2015.
The 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, the
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 the
revised guidance as a draft to allow for public comment on the
recommendations.
The reissued revised draft guidance is being issued consistent with
FDA's good guidance practices regulations (21 CFR 10.115). The reissued
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. The
revised draft guidance also refers to previously approved collection of
information found in FDA regulations.
[[Page 46992]]
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 Prescription Drugs.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors (firms) of
human and animal prescription drug products, including biological
products for use in humans.
Burden Estimate: The reissued 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 and animal prescription drugs when print
materials are directed toward consumers.
The reissued 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. Sec.
201.100(d) and 201.105(d)(1) 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 reissued revised draft guidance recommends that firms
disclose certain information to others in place of the PI to fulfill
the requirements in Sec. Sec. 201.100(d) and 201.105(d). This ``third-
party disclosure'' constitutes a ``collection of information'' under
the PRA.
FDA estimates that approximately 400 firms subject to Sec.
201.100(d) disseminate 24,000 consumer-directed print promotional
labeling pieces annually. FDA estimates that approximately 40 firms
subject to Sec. 201.105(d) disseminate 2,000 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. Please note that the requirements related to print
advertising pieces and the associated burden is already accounted for
under the requirements under 21 CFR 202.1 and its approved information
collection OMB control number 0910-0686 and, therefore, is not included
in the burden estimate reported in table 1.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Adequate information for use:
Disclosing risk information in Number of Number of Total annual Hours per
consumer-directed promotional respondents disclosures disclosures disclosure Total hours
labeling per respondent
----------------------------------------------------------------------------------------------------------------
Disclosures Related to Adequate 400 60 24,000 10 240,000
Information for Use (Sec.
201.100(d))....................
Disclosures Related to Adequate 40 50 2,000 10 20,000
Information for Use (Sec.
201.105(d))....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
This reissued revised draft guidance also refers to previously
approved collections of information found in FDA regulations with
respect to the brief summary requirement for print advertisements.
These collections of information are subject to review by OMB under the
PRA. The collection of information in Sec. 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.
Persons who commented on the version of the revised draft guidance
issued in February 2015 do not need to resubmit their comments. When
finalizing the revised draft guidance, we will review comments received
on this reissued version, as well as the version issued February 2015.
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
[[Page 46993]]
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, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.
Dated: July 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19244 Filed 8-5-15; 8:45 am]
BILLING CODE 4164-01-P