82 FR 6575 - Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling-Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range		6575-6578
FR Document		2017-01012

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers.'' This draft guidance provides information for manufacturers, packers, and distributors and their representatives (collectively ``firms'') of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively ``medical products''), about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this draft guidance to explain FDA's current thinking on commonly asked questions regarding such communications in order to provide clarity for firms.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)

[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6575-6578]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2285]


Medical Product Communications That Are Consistent With the Food 
and Drug Administration-Required Labeling--Questions and Answers; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Medical 
Product Communications That Are Consistent With the FDA-Required 
Labeling--Questions and Answers.'' This draft guidance provides 
information for manufacturers, packers, and distributors and their 
representatives (collectively ``firms'') of drugs and medical devices 
for humans, including those that are licensed as biological products, 
and animal drugs (collectively ``medical products''), about how FDA 
evaluates their medical product communications, including their 
promotional materials, that present information that is not contained 
in the FDA-required labeling for the product but that may be consistent 
with the FDA-required labeling for the product. The Agency is issuing 
this draft guidance to explain FDA's current thinking on commonly asked 
questions regarding such communications in order to provide clarity for 
firms.

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 comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a

[[Page 6576]]

third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-2285 for ``Medical Product Communications That Are 
Consistent With the FDA-Required Labeling--Questions and Answers; Draft 
Guidance for Industry; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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; 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; 
Division of Small Manufacturers, International and Consumer Assistance, 
Office of Communication, Education and Radiation Programs, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002; 
or to Communications Staff (HFV-12), 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 requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kristin Davis, Office of Policy, 
Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 
4252, Silver Spring, MD 20993-0002, 301-796-0418; or Catherine Gray, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-
0002, 301-796-1200; or Stephen Ripley, Center for Biologics Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or 
Angela Krueger, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, 
Silver Spring, MD 20993-0002, 301-796-6380; or Thomas Moskal, Center 
for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Pl. (HFV-1), Rockville, MD 20855, 240-402-6251.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Medical Product Communications That Are Consistent With the 
FDA-Required Labeling--Questions and Answers.'' This draft guidance 
provides information for firms about how FDA evaluates their medical 
product communications, including their promotional materials, that 
present information that is not contained in the FDA-required labeling 
\1\ for the product but that may be consistent with the FDA-required 
labeling for the product.
---------------------------------------------------------------------------

    \1\ As used in the draft guidance, the term FDA-required 
labeling includes the labeling reviewed and approved by FDA as part 
of the medical product marketing application review process. For 
products not subject to premarket approval, but instead subject to 
premarket notification requirements or exempt from premarket review, 
the term also includes the labeling relied on to provide adequate 
directions for use and other information required to appear on the 
label or in labeling.
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    FDA determines whether a medical product is safe and effective for 
use under the conditions prescribed, recommended, or suggested in the 
proposed labeling submitted to FDA with the product's marketing 
application or submission (and for devices, also during the 
classification process). In making this determination, FDA evaluates 
whether the conditions of use in the proposed labeling are supported by 
the required levels and types of evidence of safety and effectiveness 
and whether the benefits of using the product under those specific 
conditions of use outweigh the risks of the product. After FDA approves 
or clears a medical product, the FDA-required labeling sets forth the 
conditions of use under which the product has been shown to meet the 
relevant standard for marketing, and it provides directions and 
information on how to use the product safely and effectively under 
those conditions.
    Medical product firms have expressed interest in communicating, 
including in promotional materials, data and

[[Page 6577]]

information that are not contained in their products' FDA-required 
labeling but concern the approved/cleared uses of the products. We are 
aware that firms have questions about how FDA determines when such 
communications are consistent with the FDA-required labeling, and how 
they are viewed by FDA.
    The draft guidance describes FDA's thinking on these topics. As 
explained in the draft guidance, a firm's communication of information 
that is not contained in the product's FDA-required labeling, but that 
is determined to be consistent with the FDA-required labeling, is not 
alone considered evidence of a new intended use. However, even if a 
communication is consistent with the FDA-required labeling, the 
representations or suggestions made about the product would misbrand 
the product and could subject firms to enforcement action if the 
representations or suggestions are false or misleading. Accordingly, 
the draft guidance both describes FDA's thinking on the types of 
information that are consistent with the FDA-required labeling and 
provides general recommendations for how this information can be 
conveyed in a truthful and non-misleading way. The draft guidance also 
provides some examples to illustrate these concepts. The 
recommendations provided in the draft guidance to help ensure that 
communications are not false or misleading are specific to 
communications that are consistent with the FDA-required labeling; 
communication of information that is not consistent with the FDA-
required labeling is outside the scope of these recommendations.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a draft guidance for industry entitled ``Drug and 
Device Manufacturer Communications With Payors, Formulary Committees, 
and Similar Entities--Questions and Answers.'' This draft guidance 
provides answers to common questions regarding firms' communications of 
health care economic information about their approved prescription 
drugs to payers and similar entities. This draft guidance also 
addresses common questions relating to firms' dissemination of 
information about investigational products to payers before FDA 
approval or clearance of such products.
    In addition, FDA is announcing in this issue of the Federal 
Register that it is reopening the comment period for the notice of 
public hearing that appeared in the Federal Register of September 1, 
2016, concerning manufacturer communications regarding unapproved uses 
of approved or cleared medical products. The comment period will be 
reopened for 90 days, until April 19, 2017. As announced in the notice 
of public hearing, FDA is engaged in a comprehensive review of its 
regulations and policies governing communications by firms about 
unapproved uses of approved or cleared medical products, and the 
comments it receives will inform FDA's policy development in this area.
    FDA will consider the feedback it receives in all three of these 
dockets as the Agency continues to review its policies on firm 
communications about medical products, and interested persons may wish 
to review the documents FDA has issued in all three dockets before 
submitting comments to any of the relevant dockets.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on certain 
commonly asked questions regarding firms' communications for their 
medical products that may be consistent with the FDA-required labeling. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. 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.
    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 to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Recommended Content of Medical Product Communications That 
Are Consistent With the FDA-Required Labeling.
    Description of Respondents: Respondents to the proposed collection 
of information are manufacturers, packers, and distributors and their 
representatives (firms) of human drugs and devices, including those 
licensed as biological products, and animal drugs.
    Burden Estimate: The draft guidance includes Third-Party Disclosure 
recommendations regarding information that firms should include in 
communications that contain information not found in the FDA-required 
labeling for their medical products but that are consistent with the 
FDA-required labeling (as explained in the draft guidance) if they 
choose to publically disseminate such materials.
    Specifically, FDA recommends that various aspects of study design 
and methodology for studies relied on in such communications be 
disclosed to provide material contextual information (e.g., type of 
study, study objectives, product dosage/use regimens, control(s) used, 
patient population studied), and that material limitations related to 
the study design, methodology, and results also be disclosed in a clear 
and prominent manner to help ensure that the communications are not 
false or misleading.
    Furthermore, FDA recommends that firms accurately characterize and 
contextualize the relevant information about the product, including by 
disclosing unfavorable or inconsistent findings. FDA also recommends 
that firms disclose material contextual information from the FDA-
required labeling in these communications, such as data and information 
from studies in the FDA-required labeling that are relevant to the data 
or information presented in the communication (e.g., if a communication 
provides post-market information about the types and rates of 
occurrence of adverse events that have been observed in practice, the 
communication should also include information from the FDA-required 
labeling about the types and rates of occurrence of adverse reactions

[[Page 6578]]

observed in clinical trials to provide context).
    According to FDA data, approximately 162,000 FDA-regulated 
promotional materials are prepared by approximately 500 firms annually. 
Of these materials, we estimate approximately 5 percent contain unique 
presentations of information consistent with FDA-required labeling, as 
that term is described in the draft guidance, submitted by 
approximately 64 percent (or 324) of the firms. Anticipating the number 
of these FDA-regulated promotional materials will soon increase to 6 
percent, we estimate the 324 firms will prepare and disseminate 
annually 9,720 FDA-regulated promotional materials that contain unique 
presentations of information that is consistent with FDA-required 
labeling, as that term is described in the draft guidance, and that 
therefore are recommended to include the proposed third party 
disclosures. Based on our experience reviewing FDA-regulated 
promotional materials for medical products, we estimate it will take 
respondents approximately 4 hours per unique presentation to prepare 
and incorporate the disclosures recommended in the draft guidance, if 
they choose to disseminate this information.
    We estimate the burden of this collection of information as 
follows:

                                                Table 1--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Number of
                        Type of information                             Number of      disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent       disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms choose to                     324                30            9,720                4          38,880
 disseminate communications that are consistent with the FDA-
 required labeling.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm,
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
https://www.regulations.gov.

    Dated: January 6, 2017.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-01012 Filed 1-18-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6577

information that are not contained in communications regarding unapproved estimate of the burden of the proposed
their products’ FDA-required labeling uses of approved or cleared medical collection of information, including the
but concern the approved/cleared uses products. The comment period will be validity of the methodology and
of the products. We are aware that firms reopened for 90 days, until April 19, assumptions used; (3) ways to enhance
have questions about how FDA 2017. As announced in the notice of the quality, utility, and clarity of the
determines when such communications public hearing, FDA is engaged in a information to be collected; and (4)
are consistent with the FDA-required comprehensive review of its regulations ways to minimize the burden of the
labeling, and how they are viewed by and policies governing communications collection of information on
FDA. by firms about unapproved uses of respondents, including through the use
The draft guidance describes FDA’s approved or cleared medical products, of automated collection techniques,
thinking on these topics. As explained and the comments it receives will when appropriate, and other forms of
in the draft guidance, a firm’s inform FDA’s policy development in information technology.
communication of information that is this area. Title: Recommended Content of
not contained in the product’s FDA- FDA will consider the feedback it Medical Product Communications That
required labeling, but that is determined receives in all three of these dockets as Are Consistent With the FDA-Required
to be consistent with the FDA-required the Agency continues to review its Labeling.
labeling, is not alone considered policies on firm communications about Description of Respondents:
evidence of a new intended use. medical products, and interested Respondents to the proposed collection
However, even if a communication is persons may wish to review the of information are manufacturers,
consistent with the FDA-required documents FDA has issued in all three packers, and distributors and their
labeling, the representations or dockets before submitting comments to representatives (firms) of human drugs
suggestions made about the product any of the relevant dockets. and devices, including those licensed as
would misbrand the product and could This draft guidance is being issued biological products, and animal drugs.
subject firms to enforcement action if consistent with FDA’s good guidance Burden Estimate: The draft guidance
the representations or suggestions are practices regulation (21 CFR 10.115). includes Third-Party Disclosure
false or misleading. Accordingly, the The draft guidance, when finalized, will recommendations regarding information
draft guidance both describes FDA’s represent the current thinking of FDA that firms should include in
thinking on the types of information on certain commonly asked questions communications that contain
that are consistent with the FDA- regarding firms’ communications for information not found in the FDA-
required labeling and provides general their medical products that may be required labeling for their medical
recommendations for how this consistent with the FDA-required products but that are consistent with the
information can be conveyed in a labeling. It does not establish any rights FDA-required labeling (as explained in
truthful and non-misleading way. The for any person and is not binding on the draft guidance) if they choose to
draft guidance also provides some FDA or the public. You can use an publically disseminate such materials.
examples to illustrate these concepts. alternative approach if it satisfies the Specifically, FDA recommends that
The recommendations provided in the requirements of the applicable statutes various aspects of study design and
draft guidance to help ensure that and regulations. methodology for studies relied on in
communications are not false or such communications be disclosed to
II. Paperwork Reduction Act of 1995 provide material contextual information
misleading are specific to
communications that are consistent Under the Paperwork Reduction Act (e.g., type of study, study objectives,
with the FDA-required labeling; of 1995 (the PRA) (44 U.S.C. 3501– product dosage/use regimens, control(s)
communication of information that is 3520), Federal Agencies must obtain used, patient population studied), and
not consistent with the FDA-required approval from the Office of Management that material limitations related to the
labeling is outside the scope of these and Budget (OMB) for each collection of study design, methodology, and results
recommendations. information they conduct or sponsor. also be disclosed in a clear and
Elsewhere in this issue of the Federal ‘‘Collection of information’’ is defined prominent manner to help ensure that
Register, FDA is announcing the in 44 U.S.C. 3502(3) and 5 CFR the communications are not false or
availability of a draft guidance for 1320.3(c) and includes Agency requests misleading.
industry entitled ‘‘Drug and Device or requirements that members of the Furthermore, FDA recommends that
Manufacturer Communications With public submit reports, keep records, or firms accurately characterize and
Payors, Formulary Committees, and provide information to a third party. contextualize the relevant information
Similar Entities—Questions and Section 3506(c)(2)(A) of the PRA (44 about the product, including by
Answers.’’ This draft guidance provides U.S.C. 3506(c)(2)(A)) requires Federal disclosing unfavorable or inconsistent
answers to common questions regarding Agencies to provide a 60-day notice in findings. FDA also recommends that
firms’ communications of health care the Federal Register concerning each firms disclose material contextual
economic information about their proposed collection of information information from the FDA-required
approved prescription drugs to payers before submitting the collection to OMB labeling in these communications, such
and similar entities. This draft guidance for approval. To comply with this as data and information from studies in
also addresses common questions requirement, FDA is publishing notice the FDA-required labeling that are
relating to firms’ dissemination of of the proposed collection of relevant to the data or information
information about investigational information set forth in this document. presented in the communication (e.g., if
products to payers before FDA approval With respect to the following a communication provides post-market
mstockstill on DSK3G9T082PROD with NOTICES

or clearance of such products. collection of information, FDA invites information about the types and rates of
In addition, FDA is announcing in comments on these topics: (1) Whether occurrence of adverse events that have
this issue of the Federal Register that it the proposed collection of information been observed in practice, the
is reopening the comment period for the is necessary for the proper performance communication should also include
notice of public hearing that appeared of FDA’s functions, including whether information from the FDA-required
in the Federal Register of September 1, the information will have practical labeling about the types and rates of
2016, concerning manufacturer utility; (2) the accuracy of FDA’s occurrence of adverse reactions

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6578 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices

observed in clinical trials to provide (or 324) of the firms. Anticipating the third party disclosures. Based on our
context). number of these FDA-regulated experience reviewing FDA-regulated
According to FDA data, promotional materials will soon promotional materials for medical
approximately 162,000 FDA-regulated increase to 6 percent, we estimate the products, we estimate it will take
promotional materials are prepared by 324 firms will prepare and disseminate respondents approximately 4 hours per
approximately 500 firms annually. Of annually 9,720 FDA-regulated unique presentation to prepare and
these materials, we estimate promotional materials that contain incorporate the disclosures
approximately 5 percent contain unique unique presentations of information that recommended in the draft guidance, if
presentations of information consistent is consistent with FDA-required they choose to disseminate this
with FDA-required labeling, as that term labeling, as that term is described in the information.
is described in the draft guidance, draft guidance, and that therefore are We estimate the burden of this
submitted by approximately 64 percent recommended to include the proposed collection of information as follows:

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
Type of information disclosures per burden per Total hours
respondents disclosures
respondent disclosure

Recommended information to be included when firms
choose to disseminate communications that are con-
sistent with the FDA-required labeling ............................. 324 30 9,720 4 38,880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access comment on proposed data collection program and grants policies and
Persons with access to the Internet projects, HRSA announces plans to requirements under the statute. By
may obtain the draft guidance at either submit an Information Collection regulation, recipients are required to
Request (ICR), described below, to the submit financial reports annually to
http://www.fda.gov/Drugs/Guidance Office of Management and Budget HRSA and the A&E Reports and the CLC
ComplianceRegulatoryInformation/ (OMB). Prior to submitting the ICR to are HAB’s mechanism to implement that
Guidances/default.htm, OMB, HRSA seeks comments from the requirement. Recipients funded under
http://www.fda.gov/BiologicsBlood public regarding the burden estimate, Parts A, B, C, and D of the Ryan White
Vaccines/GuidanceCompliance below, or any other aspect of the ICR. HIV/AIDS Program (codified under Title
RegulatoryInformation/Guidances/ DATES: Comments on this ICR must be XXVI of the Public Health Service Act)
default.htm, received no later than March 20, 2017. are required to report financial data to
http://www.fda.gov/MedicalDevices/ HRSA at the beginning (Allocations
ADDRESSES: Submit your comments to
DeviceRegulationandGuidance/ Report) and at the end of their grant
GuidanceDocuments/default.htm, paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance cycle (Expenditures Report). Recipients
http://www.fda.gov/AnimalVeterinary/ funded under Parts A and B are required
GuidanceComplianceEnforcement/ Officer, Room 14N–39, 5600 Fishers
Lane, Rockville, MD 20857. to report information about their service
GuidanceforIndustry/default.htm, or provider contracts in the CLC.
https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: To
request more information on the The forms will continue to require
Dated: January 6, 2017. proposed project or to obtain a copy of recipients to report on how funds are
Jeremy Sharp, the data collection plans and draft allocated and spent on core medical and
Deputy Commissioner for Policy, Planning, instruments, email paperwork@hrsa.gov non-core services for persons living
Legislation, and Analysis. or call the HRSA Information Collection with HIV, and on various program
[FR Doc. 2017–01012 Filed 1–18–17; 8:45 am] Clearance Officer at (301) 443–1984. components, such as administration,
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: When planning and evaluation, and quality
submitting comments or requesting management. The A & E Reports are
information, please include the identical in the types of information
DEPARTMENT OF HEALTH AND information request collection title for they collect. However, the first report
HUMAN SERVICES reference. tracks the allocation of the award at the
Information Collection Request Title: beginning of the grant cycle and the
Health Resources and Services second report tracks actual expenditures
Ryan White HIV/AIDS Program:
Administration (including carryover dollars) at the end
Allocation and Expenditure Forms.
OMB No. 0915–0318—Revision. of the grant cycle. The CLC form
Agency Information Collection identifies a recipient’s contracts with
Abstract: HRSA’s HIV/AIDS Bureau
Activities: Proposed Collection: Public service providers for the current grant
(HAB) administers the Ryan White HIV/
Comment Request; Ryan White HIV/ year, the contract amount, and the types
AIDS Program authorized under Title
AIDS Program: Allocation and of services being provided.
XXVI of the Public Health Service Act
Expenditure Forms
as amended by the Ryan White HIV/ Need and Proposed Use of the
mstockstill on DSK3G9T082PROD with NOTICES

AGENCY: Health Resources and Services AIDS Treatment Extension Act of 2009. Information: Accurate allocation,
Administration (HRSA), Department of The Ryan White HIV/AIDS Program expenditure, and service contract
Health and Human Services. Allocation and Expenditure Reports records of the recipients receiving Ryan
ACTION: Notice. (A&E Reports), in conjunction with the White HIV/AIDS Program funding are
Consolidated List of Contractors (CLC), critical to the implementation of the law
SUMMARY: In compliance with the enables HRSA to monitor and track the and thus are necessary for HRSA to
requirement for opportunity for public use of grant funds for compliance with fulfill its responsibilities. The primary

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Document Created: 2018-02-01 15:15:14
Document Modified: 2018-02-01 15:15:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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 comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 19, 2017.
Contact		Kristin Davis, Office of Policy, Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 301-796-0418; or Catherine Gray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993- 0002, 301-796-1200; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380; or Thomas Moskal, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-1), Rockville, MD 20855, 240-402-6251.
FR Citation		82 FR 6575

82 FR 6575 - Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling-Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 12 (January 19, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration