80 FR 44135 - Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access; Public Meeting, Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 142 (July 24, 2015)

Page Range		44135-44137
FR Document		2015-18149
Federal Register, Volume 80 Issue 142 (Friday, July 24, 2015)
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44135-44137]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0502]


Risk Evaluation and Mitigation Strategies: Understanding and 
Evaluating Their Impact on the Health Care Delivery System and Patient 
Access; Public Meeting, Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA or Agency) is announcing a 
public meeting entitled ``Risk Evaluation and Mitigation Strategies 
(REMS): Understanding and Evaluating Their Impact on the Health Care 
Delivery System and Patient Access''. The purpose of the public meeting 
is to engage in constructive dialogue and information sharing among 
regulators, the scientific community, the pharmaceutical industry, 
public health agencies, patients, patient advocates, health care system 
administrators, prescribers, dispensers, hospitals, infusion centers, 
health informatics experts, third-party payers, distributors, and the 
general public concerning the impact of REMS on the health care 
delivery system, including the impact on patients and health care 
providers. The discussion will focus on strategies for characterizing 
and evaluating the impact of REMS on the health care delivery system 
and on patient access to drugs subject to REMS.
    The primary focus of this meeting will be on REMS with Elements To 
Assure Safe Use (ETASU); however, the meeting will also include 
discussion of issues that may apply to all REMS. The input from this 
meeting and the public docket comments will be used to inform ongoing 
Agency initiatives related to optimizing REMS design, implementation, 
and assessment.
    Dates and Times: The meeting will be held on October 5, 2015, from 
8 a.m. to 5 p.m. and October 6, 2015, from 8 a.m. to 1 p.m.
    Location: The meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Participants must enter 
through Building 1 and undergo security screening. For parking and 
security information, please visit http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Please arrive early to ensure time for parking and 
security screening.
    Contact Persons for meeting background and content: Megan Moncur, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
[email protected] .
    For registration, oral presentations, special accommodations, and 
other meeting logistics: Cherice Holloway, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, Phone 301-796-4909, FAX: 301-796-9832, 
[email protected].
    Registration and Requests for Oral Presentations: Registration is 
free and available on a first-come, first-served basis. You must 
register by September 21, 2015. Seating is limited, so register early. 
FDA may limit the number of participants from each organization. If 
time and space permit, onsite registration on the day of the meeting 
will be available. To register for this

[[Page 44136]]

meeting, please visit FDA's Drugs News & Events--Meetings, Conferences, 
& Workshops calendar at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm and select this meeting from the events list. If you need 
special accommodations because of a disability, please contact Cherice 
Holloway (see Contact Persons) at least 7 days before the meeting. 
Those without Internet access should contact Cherice Holloway to 
register.
    This meeting includes public comment sessions in which FDA is 
seeking input on improved approaches for understanding, evaluating, and 
minimizing burden on the health care delivery system to the extent 
practicable and for helping to assure patient access to drugs that are 
subject to REMS. If you would like to present during a session, please 
identify the topic(s) you will address during registration (see section 
II).
    FDA will do its best to accommodate requests to speak. FDA urges 
individuals and organizations with common interests to coordinate and/
or request time for a joint presentation. Following the close of 
registration, FDA will allot time for each presentation and notify 
presenters by September 28, 2015. Do not present or distribute 
commercial or promotional material during the meeting. Registered 
presenters should check in at the registration desk before the meeting.
    Live Webcast of the Meeting: To view the Connect Pro Webcast of 
this meeting, you must register online by 4 p.m., September 21, 2015. 
Webcast connections are limited, so register early. Organizations 
should register all viewers but access the Webcast using one connection 
per location.
    Webcast viewers will be sent system requirements after registration 
and will be sent connection information after September 28, 2015. Visit 
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm 
for the Connect Pro Connection Test. To get a quick overview of Connect 
Pro, visit http://www.adobe.com/go/connectpro_overview. (FDA has 
verified the Web site addresses in this notice but is not responsible 
for any subsequent address changes after this document publishes in the 
Federal Register.)
    Comments: FDA is holding this public meeting to obtain information 
on improved strategies for evaluating and minimizing the burden of REMS 
on the health care delivery system to the extent practicable and their 
impact on patient access to the drugs covered by such programs. FDA is 
opening a public docket for comments to be submitted to the Agency on 
the issues and questions presented during the meeting. Regardless of 
attendance at the public meeting, interested persons may submit 
electronic or paper comments to FDA's Division of Dockets Management by 
November 2, 2015.
    Submit electronic comments to http://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. Send only one set of comments. Identify all comments with the 
docket number found in brackets in the heading of this document. When 
addressing specific topics (see section II), please identify the topic. 
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 http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. The 
transcript may be viewed at the Division of Dockets Management (see 
Comments). A transcript will also be available in either hard copy or 
on CD-ROM after submission of a Freedom of Information request. Written 
requests are to be sent to the Division of Freedom of Information 
(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION:

I. Background

    This meeting builds on prior stakeholder feedback on the design, 
implementation, and assessment of REMS, including feedback obtained 
through public meetings, stakeholder outreach, and comments to the 
public docket, including the recommendations and suggestions recently 
summarized in the Agency's report entitled ``Standardizing and 
Evaluating Risk Evaluation and Mitigation Strategies'' (the 
Standardizing and Evaluating REMS Report).\1\ The report also describes 
the Agency's findings concerning strategies to standardize REMS, where 
appropriate, with the goal of reducing the burden of implementing REMS 
on health care providers, patients, and others in various health care 
settings.
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    \1\ In the Federal Register of September 23, 2014 (79 FR 56816), 
FDA published a notice announcing the availability of this draft 
report. The report is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm415751.pdf.
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    The Agency seeks to build on this foundation by updating 
stakeholders and obtaining their feedback on some of our current and 
proposed initiatives aimed at anticipating and minimizing REMS' burden 
on the health care delivery system, helping to assure access to drugs 
that are subject to REMS with ETASU, and obtaining stakeholder 
recommendations on additional approaches to accomplish these goals. The 
Agency recognizes that REMS can impose burden on the health care 
delivery system. The statute requires ETASU to be commensurate with the 
specific serious risks listed in a drug's labeling, and, considering 
such risks, not be unduly burdensome on patient access to the drug, 
and, to the extent practicable, to minimize burden on the health care 
delivery system. We are also seeking input on the methods for 
evaluating REMS' burden on the health care delivery system and their 
impact on patient access to drugs.
    The primary focus of this meeting will be on REMS with ETASU see 
section 505(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355-1(f)); however, the meeting will also include discussion of issues 
that may apply to all REMS.

II. Who Is the Target Audience and Who Should Attend This Public 
Meeting?

    This meeting is open to all interested parties. The target audience 
is comprised of regulators, the scientific community, the 
pharmaceutical industry, public health Agencies, patients, patient 
advocates, health care system administrators, prescribers, dispensers, 
hospitals, infusion centers, health informatics experts, third-party 
payers, distributors, and the general public who are interested in 
providing input on approaches for both anticipating and minimizing 
health care delivery system burden and for helping to assure patient 
access to drugs that are subject to REMS, as well as those interested 
in improving the approaches used to evaluate the burden of REMS on the 
health care delivery system and their impact on patient access.

III. What Are the Topics We Intend to Discuss at the Public Meeting?

    The meeting will include panel discussions and individual 
presentations. The main questions that will be considered are as 
follows: (1) How to anticipate and minimize the burden of REMS on the 
health care delivery system and patient access; and (2) how to improve 
the quality and effectiveness of methods used to evaluate REMS' burden 
on the health care delivery system and impact on patient access.

[[Page 44137]]

    FDA will begin the meeting by soliciting feedback regarding how 
stakeholders, such as patients and health care providers, think about 
burden related to REMS. The meeting will then focus on strategies for 
anticipating and addressing REMS burden and access issues in several 
broad topic areas (including several areas identified in the key 
opinions and recommendations from stakeholders in the Standardizing and 
Evaluating REMS Report). Potential discussion topics are described in 
this document. For topics related to strategies for minimizing burden 
and barriers to patient access (topics 1-3), FDA will present ongoing 
and planned Agency initiatives, solicit feedback on these initiatives, 
and ask for feedback on other opportunities for anticipating and 
minimizing burden and patient access issues.
    Potential topics for discussion include the following:
     Topic 1: Understanding the stakeholder perspective.
    Discussion will focus on gaining a better understanding of how 
stakeholders, such as patients, health care providers, dispensers, and 
others, think about burden and access issues related to REMS--for 
example, understanding the different dimensions of burden (e.g., 
administrative, logistical, workflow) and better understanding the 
different types of patient access issues that are implicated by REMS.
     Topic 2: Improved communication about the existence of a 
REMS and about what is required of stakeholders under that REMS.
    Discussion will focus on strategies to improve communications about 
REMS, including communications about the existence of a particular REMS 
or the requirements under a particular REMS program, and how to improve 
the clarity of REMS materials.
     Topic 3: Improved integration of activities required under 
a REMS.
    Discussion will focus on two closely related subtopics: (1) 
Strategies to improve the integration of REMS requirements into the 
health care delivery system through process improvement (e.g., 
streamlining REMS processes that have an impact on stakeholder workflow 
or the care process, and reducing redundancies by leveraging existing 
training or certification requirements to meet REMS requirements); and 
(2) strategies to integrate REMS into electronic health care systems 
(e.g., electronic health records, decision support systems, and 
pharmacy management systems).
     Topic 4: Improved methods for measuring the burden of REMS 
on the health care delivery system and the impact on patient access.
    Discussion will focus on identifying the most effective methods for 
evaluating the burden of REMS on the health care delivery system and 
the impact on patient access, with a goal of not only characterizing 
and quantifying these effects, but also identifying opportunities for 
improvements to a REMS program and better understanding the effect of 
changes to a program. This may include discussion of how to address 
methodological challenges in the measurement of burden and access, and 
how to incorporate stakeholder input into REMS design and assessment.
    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 public meeting, and the background material will be posted on FDA's 
Web site after the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm, and to the docket at http://www.regulations.gov.

    Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18149 Filed 7-23-15; 8:45 am]
 BILLING CODE 4164-01-P
Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 44135

Families is soliciting public comment has been approved by the Office of agencies, patients, patient advocates,
on the specific aspects of the Management and Budget (OMB) under health care system administrators,
information collection described above. the Paperwork Reduction Act of 1995. prescribers, dispensers, hospitals,
Copies of the proposed collection of FOR FURTHER INFORMATION CONTACT: FDA infusion centers, health informatics
information can be obtained and PRA Staff, Office of Operations, Food experts, third-party payers, distributors,
comments may be forwarded by writing and Drug Administration, 8455 and the general public concerning the
to the Administration for Children and Colesville Rd., COLE–14526, Silver impact of REMS on the health care
Families, Office of Planning, Research Spring, MD 20993–0002, delivery system, including the impact
and Evaluation, 370 L’Enfant PRAStaff@fda.hhs.gov. on patients and health care providers.
Promenade SW., Washington, DC 20447, The discussion will focus on strategies
SUPPLEMENTARY INFORMATION: On May
Attn: ACF Reports Clearance Officer. for characterizing and evaluating the
26, 2015, the Agency submitted a impact of REMS on the health care
Email address: infocollection@ proposed collection of information
acf.hhs.gov. All requests should be delivery system and on patient access to
entitled, ‘‘Petition to Request an drugs subject to REMS.
identified by the title of the information Exemption from 100 Percent Identity
collection. The primary focus of this meeting will
Testing of Dietary Ingredients: CGMP in be on REMS with Elements To Assure
The Department specifically requests Manufacturing, Packaging, Labeling or
comments on: (a) Whether the proposed Safe Use (ETASU); however, the
Holding Operations for Dietary meeting will also include discussion of
collection of information is necessary Supplements’’ to OMB for review and
for the proper performance of the issues that may apply to all REMS. The
clearance under 44 U.S.C. 3507. An input from this meeting and the public
functions of the agency, including Agency may not conduct or sponsor,
whether the information shall have docket comments will be used to inform
and a person is not required to respond ongoing Agency initiatives related to
practical utility; (b) the accuracy of the to, a collection of information unless it
agency’s estimate of the burden of the optimizing REMS design,
displays a currently valid OMB control implementation, and assessment.
proposed collection of information; (c) number. OMB has now approved the
the quality, utility, and clarity of the Dates and Times: The meeting will be
information collection and has assigned held on October 5, 2015, from 8 a.m. to
information to be collected; and (d) OMB control number 0910–0608. The
ways to minimize the burden of the 5 p.m. and October 6, 2015, from 8 a.m.
approval expires on July 31, 2018. A to 1 p.m.
collection of information on copy of the supporting statement for this Location: The meeting will be held at
respondents, including through the use information collection is available on the FDA White Oak Campus, 10903
of automated collection techniques or the Internet at http://www.reginfo.gov/ New Hampshire Ave., Bldg. 31
other forms of information technology. public/do/PRAMain. Conference Center, the Great Room (Rm.
Consideration will be given to
Dated: July 20, 2015. 1503), Silver Spring, MD 20993–0002.
comments and suggestions submitted
Leslie Kux, Participants must enter through
within 60 days of this publication.
Associate Commissioner for Policy.
Building 1 and undergo security
Robert Sargis, screening. For parking and security
[FR Doc. 2015–18140 Filed 7–23–15; 8:45 am]
Reports Clearance Officer. information, please visit http://
BILLING CODE 4164–01–P
[FR Doc. 2015–18203 Filed 7–23–15; 8:45 am] www.fda.gov/AboutFDA/
BILLING CODE 4184–01–P
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
DEPARTMENT OF HEALTH AND
ucm241740.htm. Please arrive early to
HUMAN SERVICES
DEPARTMENT OF HEALTH AND ensure time for parking and security
HUMAN SERVICES Food and Drug Administration screening.
Contact Persons for meeting
Food and Drug Administration [Docket No. FDA–2013–N–0502] background and content: Megan
Moncur, Center for Drug Evaluation and
[Docket No. FDA–2013–N–1152] Risk Evaluation and Mitigation Research, Food and Drug
Strategies: Understanding and Administration, 10903 New Hampshire
Agency Information Collection Evaluating Their Impact on the Health
Activities; Announcement of Office of Ave., Silver Spring, MD 20993–0002,
Care Delivery System and Patient REMSMeetingOct2015@fda.hhs.gov .
Management and Budget Approval; Access; Public Meeting, Request for
Petition To Request an Exemption For registration, oral presentations,
Comments special accommodations, and other
From 100 Percent Identity Testing of
Dietary Ingredients: CGMP in AGENCY: Food and Drug Administration, meeting logistics: Cherice Holloway,
Manufacturing, Packaging, Labeling or HHS. Center for Drug Evaluation and
Holding Operations for Dietary ACTION: Notice of public meeting; Research, Food and Drug
Supplements request for comments. Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
AGENCY: Food and Drug Administration, The Food and Drug Administration Phone 301–796–4909, FAX: 301–796–
HHS. (FDA or Agency) is announcing a public 9832, cherice.holloway@fda.hhs.gov.
ACTION: Notice. meeting entitled ‘‘Risk Evaluation and Registration and Requests for Oral
Mitigation Strategies (REMS): Presentations: Registration is free and
asabaliauskas on DSK5VPTVN1PROD with NOTICES

SUMMARY: The Food and Drug Understanding and Evaluating Their available on a first-come, first-served
Administration (FDA) is announcing Impact on the Health Care Delivery basis. You must register by September
that a collection of information entitled, System and Patient Access’’. The 21, 2015. Seating is limited, so register
‘‘Petition to Request an Exemption from purpose of the public meeting is to early. FDA may limit the number of
100 Percent Identity Testing of Dietary engage in constructive dialogue and participants from each organization. If
Ingredients: CGMP in Manufacturing, information sharing among regulators, time and space permit, onsite
Packaging, Labeling or Holding the scientific community, the registration on the day of the meeting
Operations for Dietary Supplements’’ pharmaceutical industry, public health will be available. To register for this

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Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 44137

FDA will begin the meeting by health care delivery system and the DATES: Although you can comment on
soliciting feedback regarding how impact on patient access. any guidance at any time (see 21 CFR
stakeholders, such as patients and Discussion will focus on identifying 10.115(g)(5)), to ensure that we consider
health care providers, think about the most effective methods for your comment on this draft guidance
burden related to REMS. The meeting evaluating the burden of REMS on the before we begin work on the final
will then focus on strategies for health care delivery system and the version of the guidance, submit either
anticipating and addressing REMS impact on patient access, with a goal of electronic or written comments by
burden and access issues in several not only characterizing and quantifying October 7, 2015.
broad topic areas (including several these effects, but also identifying ADDRESSES: Submit written requests for
areas identified in the key opinions and opportunities for improvements to a single copies of the draft guidance to
recommendations from stakeholders in REMS program and better Charlotte A. Christin, Office of
the Standardizing and Evaluating REMS understanding the effect of changes to a Compliance, Center for Food Safety and
Report). Potential discussion topics are program. This may include discussion Applied Nutrition (HFS–605), Food and
described in this document. For topics of how to address methodological Drug Administration, 5100 Paint Branch
related to strategies for minimizing challenges in the measurement of Pkwy., College Park, MD 20740. Send
burden and barriers to patient access burden and access, and how to two self-addressed adhesive labels to
(topics 1–3), FDA will present ongoing incorporate stakeholder input into assist that office in processing your
and planned Agency initiatives, solicit REMS design and assessment. request. See the SUPPLEMENTARY
feedback on these initiatives, and ask for FDA intends to make background
INFORMATION section for electronic
feedback on other opportunities for material available to the public no later
access to the draft guidance.
anticipating and minimizing burden and than 2 business days before the meeting. Submit electronic comments on the
patient access issues. If FDA is unable to post the background
draft guidance to http://
Potential topics for discussion include material on its Web site prior to the
www.regulations.gov. Submit written
the following: meeting, the background material will
comments to the Division of Dockets
• Topic 1: Understanding the be made publicly available at the
Management (HFA–305), Food and Drug
stakeholder perspective. location of the public meeting, and the
Administration, 5630 Fishers Lane, Rm.
Discussion will focus on gaining a background material will be posted on
1061, Rockville, MD 20852.
better understanding of how FDA’s Web site after the meeting at
stakeholders, such as patients, health http://www.fda.gov/Drugs/NewsEvents/ FOR FURTHER INFORMATION CONTACT:
care providers, dispensers, and others, ucm132703.htm, and to the docket at Charlotte A. Christin, Center for Food
think about burden and access issues http://www.regulations.gov. Safety and Applied Nutrition (HFS–
related to REMS—for example, 605), Food and Drug Administration,
Dated: July 20, 2015.
understanding the different dimensions 5100 Paint Branch Pkwy., College Park,
Leslie Kux, MD 20740, 240–402–3708.
of burden (e.g., administrative, Associate Commissioner for Policy.
logistical, workflow) and better SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–18149 Filed 7–23–15; 8:45 am]
understanding the different types of I. Background
BILLING CODE 4164–01–P
patient access issues that are implicated
by REMS. We are announcing the availability of
• Topic 2: Improved communication a draft guidance for industry and FDA
DEPARTMENT OF HEALTH AND staff entitled ‘‘Third-Party Auditor/
about the existence of a REMS and
HUMAN SERVICES Certification Body Accreditation for
about what is required of stakeholders
under that REMS. Food Safety Audits: Model
Food and Drug Administration
Discussion will focus on strategies to Accreditation Standards’’ (draft
improve communications about REMS, [Docket No. FDA–2011–N–0146] guidance). This draft guidance is being
including communications about the made available consistent with our good
Third-Party Auditor/Certification Body guidance practices regulation (21 CFR
existence of a particular REMS or the
Accreditation for Food Safety Audits: 10.115). The draft guidance, when
requirements under a particular REMS
Model Accreditation Standards; Draft finalized, will represent our current
program, and how to improve the clarity
Guidance for Industry and Food and thinking on ‘‘Third-Party Auditor/
of REMS materials.
• Topic 3: Improved integration of Drug Administration Staff; Availability Certification Body Accreditation for
activities required under a REMS. AGENCY: Food and Drug Administration, Food Safety Audits: Model
Discussion will focus on two closely HHS. Accreditation Standards.’’ It does not
related subtopics: (1) Strategies to ACTION: Notice. create or confer any rights for or on any
improve the integration of REMS person and does not operate to bind
requirements into the health care SUMMARY: The Food and Drug FDA or the public. An alternative
delivery system through process Administration (FDA) is announcing the approach may be used if such an
improvement (e.g., streamlining REMS availability of a draft guidance for approach satisfies the requirements of
processes that have an impact on industry and FDA staff entitled ‘‘Third- the applicable statutes and regulations.
stakeholder workflow or the care Party Auditor/Certification Body Section 808 of the Federal Food, Drug,
process, and reducing redundancies by Accreditation for Food Safety Audits: and Cosmetic Act (the FD&C Act) (21
leveraging existing training or Model Accreditation Standards.’’ The U.S.C. 384d) was added by FSMA and
asabaliauskas on DSK5VPTVN1PROD with NOTICES

certification requirements to meet REMS draft guidance, when finalized, will directs FDA to establish a program for
requirements); and (2) strategies to contain FDA recommendations on third- the recognition of accreditation bodies
integrate REMS into electronic health party auditor/certification body that accredit third-party auditors/
care systems (e.g., electronic health qualifications for accreditation to certification bodies to conduct food
records, decision support systems, and conduct food safety audits and to issue safety audits and to issue food and/or
pharmacy management systems). food and/or facility certifications under facility certifications that FDA may use
• Topic 4: Improved methods for an FDA program required by the FDA in certain circumstances to facilitate the
measuring the burden of REMS on the Food Safety Modernization Act (FSMA). entry of foods presented for import.

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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 public meeting; request for comments.
FR Citation		80 FR 44135
80 FR 44135 - Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access; Public Meeting, Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 142 (July 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
