Food and Drug Administration's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary; Draft Guidance for Industry; Availability, 64911-64913 [2016-22689]

Download as PDF Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices Form ORR–3 and ORR–4 to administer the Unaccompanied Refugee Minors (URM) program. The ORR–3 (Placement Report) is submitted to ORR by the State agency at the minor’s initial placement in the resettlement State within 30 days of the placement, and whenever there is a change in the minor’s status, including termination from the program, within 60 days of the change or closure of the case. The ORR–4 (Outcomes Report) is submitted every 12 months beginning on the 12 month anniversary date of initial placement to record outcomes of the child’s progress toward the goals listed in the child’s case plan. An ORR– 4 is also submitted along with the initial ORR–3 report for minors 17 years old or 64911 above to establish a baseline of information for the youth related to independent living and/or educational plans. The ORR regulations per 45 CFR 400.120 describe specific URM program reporting requirements. Respondents: State governments. ANNUAL BURDEN ESTIMATES Instrument Number of responses per respondent Average burden hours per response 15 15 Estimated responses 178 ...... Estimated responses 127 ...... 0.25 (15 min) ......................... 1.5 (1 hour and 30 min) ......... Estimated 667.5. Estimated 2,857.5. ........................ ................................................ ................................................ 3,525. Number of respondents ORR–3 ................................... ORR–4 ................................... Estimated Total Annual Burden Hours. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, email: OIRA_ SUBMISSION@OMB.EOP.GOV. Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016–22678 Filed 9–20–16; 8:45 am] mstockstill on DSK3G9T082PROD with NOTICES BILLING CODE 4184–01–P VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–2730] Food and Drug Administration’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.’’ This draft guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several being developed to fulfill performance goals that FDA agreed to satisfy in the context of the fifth reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act V). 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 November 21, 2016. SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 ADDRESSES: Total burden hours 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 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, E:\FR\FM\21SEN1.SGM 21SEN1 mstockstill on DSK3G9T082PROD with NOTICES 64912 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 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–2730 for the ‘‘FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary; Draft Guidance for Industry.’’ 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: https://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 VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Aaron Sherman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993, 240–402– 0493, Aaron.Sherman@fda.hhs.gov; 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.’’ The Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110–85) created section 505–1 of the FD&C Act (21 U.S.C. 355–1),1 which authorizes FDA to require a REMS for certain drugs if FDA determines that a REMS is necessary to ensure that the benefits of the drug outweigh its risks (see section 505–1(a) of the FD&C Act). A REMS is a required risk management strategy that can include one or more elements to ensure that the benefits of a drug outweigh its risks (see section 505–1(e) of the FD&C Act). A REMS may consist of a Medication Guide, a patient package insert, and/or a communication plan (section 505–1(e)(2) to (e)(3) of the FD&C Act). FDA may also require certain elements to assure safe use (ETASU) as part of a REMS for a drug (see section 505–1(f) of the FD&C Act). (The ETASU can include, for example, 1 Section 505–1 of the FD&C Act applies to applications for prescription drugs submitted or approved under subsections 505(b) (i.e., new drug applications) or (j) (i.e., abbreviated new drug applications) of the FD&C Act and to applications submitted or approved under section 351 (i.e., biologics license applications) of the Public Health Service Act (42 U.S.C. 262). In this document, unless otherwise specified, the term ‘‘drug’’ refers to drug and biological products (or biologics). PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 requirements that health care providers who prescribe the drug have particular training or experience, that patients using the drug be monitored, or that the drug be dispensed to patients with evidence or other documentation of safe use conditions (Id.). The ETASU may also include an implementation system through which the sponsor is able to monitor, evaluate, and improve implementation of the ETASU (see section 505–1(f)(4) of the FD&C Act).) Finally, REMS generally must have a timetable for submission of assessments of the strategy (see section 505–1(d) of the FD&C Act). FDA can require a REMS before initial approval of a new drug application or, should FDA become aware of ‘‘new safety information’’ (as defined in section 505–1(b)(3) of the FD&C Act) about a drug and determine that a REMS is necessary to ensure that the benefits of the drug outweigh its risks, after the drug has been approved (see section 505–1(a)(2) of the FD&C Act). FDA’s determination as to whether a REMS is necessary for a particular drug is a complex, drug-specific inquiry, reflecting an analysis of multiple, interrelated factors. In conducting this analysis, FDA considers whether (based on premarketing or postmarketing risk assessments) there is a particular risk associated with the use of the drug that, on balance, outweighs its benefits and whether additional interventions beyond FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks. If FDA determines that additional interventions are necessary to ensure that the benefits of a drug outweigh its risks, FDA considers what the goals of a proposed REMS to address these risks would be and what specific elements could help meet those goals. If a REMS can be designed that FDA expects will meet the relevant goals and not unduly impede patient access to the drug, then FDA will generally approve the drug with a REMS (or, if the drug is already being marketed, require that a REMS be imposed for the drug). If FDA believes that the drug’s risks would exceed its benefits even if FDA were to require a REMS for the drug, FDA will not approve the drug or may consider seeking withdrawal of the drug if it is already being marketed. FDAAA requires FDA to consider the following six factors 2 in making a 2 Section 505–1(a)(1) of the FD&C Act requires the Agency to consider these factors in determining whether a REMS is necessary for a new drug. FDA also generally considers these factors in determining whether (based on new safety information), a REMS is necessary for a drug that is the subject of an approved application. E:\FR\FM\21SEN1.SGM 21SEN1 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices decision about whether to require a REMS: • The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug • The expected benefit of the drug with respect to the disease or condition • The seriousness of the disease or condition that is to be treated with the drug • Whether the drug is a new molecular entity • The expected or actual duration of treatment with the drug • The estimated size of the population likely to use the drug These six factors influence FDA’s decisions with respect to both whether a REMS is required for a particular drug and what type of REMS might be necessary (i.e., what specific elements/ tools should be included as part of the REMS). FDA makes decisions about requiring a REMS as part of a benefitrisk determination for a drug after an evaluation that includes integrated consideration of each of the statutory factors. No single factor, by itself, is determinative as to whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks. This guidance describes how FDA considers each of these factors in conducting its REMS analysis. 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 how the Agency applies statutory factors in determining when a REMS is necessary. 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. mstockstill on DSK3G9T082PROD with NOTICES II. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: September 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–22689 Filed 9–20–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–2561] Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ‘‘Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.’’ This draft guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. This draft guidance is not final nor is it in effect at this time. 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 of 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 November 21, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: 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 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. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 64913 • 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–2561 for ‘‘Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.’’ 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 E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64911-64913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22689]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2730]

Food and Drug Administration's Application of Statutory Factors
in Determining When a Risk Evaluation and Mitigation Strategy Is
Necessary; 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 ``FDA's
Application of Statutory Factors in Determining When a REMS Is
Necessary.'' This draft guidance is intended to clarify how FDA applies
the factors set forth in the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) in determining whether a risk evaluation and mitigation
strategy (REMS) is necessary to ensure that the benefits of a drug
outweigh its risks. This guidance is one of several being developed to
fulfill performance goals that FDA agreed to satisfy in the context of
the fifth reauthorization of the prescription drug user fee program
(the Prescription Drug User Fee Act V).

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 November 21, 2016.

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 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,

[[Page 64912]]

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-2730 for the ``FDA's Application of Statutory Factors in
Determining When a REMS Is Necessary; Draft Guidance for Industry.''
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: https://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; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Aaron Sherman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993, 240-402-
0493, Aaron.Sherman@fda.hhs.gov; 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.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``FDA's Application of Statutory Factors in Determining When a
REMS Is Necessary.'' The Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85) created section 505-1 of the FD&C Act (21
U.S.C. 355-1),\1\ which authorizes FDA to require a REMS for certain
drugs if FDA determines that a REMS is necessary to ensure that the
benefits of the drug outweigh its risks (see section 505-1(a) of the
FD&C Act). A REMS is a required risk management strategy that can
include one or more elements to ensure that the benefits of a drug
outweigh its risks (see section 505-1(e) of the FD&C Act). A REMS may
consist of a Medication Guide, a patient package insert, and/or a
communication plan (section 505-1(e)(2) to (e)(3) of the FD&C Act). FDA
may also require certain elements to assure safe use (ETASU) as part of
a REMS for a drug (see section 505-1(f) of the FD&C Act). (The ETASU
can include, for example, requirements that health care providers who
prescribe the drug have particular training or experience, that
patients using the drug be monitored, or that the drug be dispensed to
patients with evidence or other documentation of safe use conditions
(Id.). The ETASU may also include an implementation system through
which the sponsor is able to monitor, evaluate, and improve
implementation of the ETASU (see section 505-1(f)(4) of the FD&C Act).)
Finally, REMS generally must have a timetable for submission of
assessments of the strategy (see section 505-1(d) of the FD&C Act). FDA
can require a REMS before initial approval of a new drug application
or, should FDA become aware of ``new safety information'' (as defined
in section 505-1(b)(3) of the FD&C Act) about a drug and determine that
a REMS is necessary to ensure that the benefits of the drug outweigh
its risks, after the drug has been approved (see section 505-1(a)(2) of
the FD&C Act).
---------------------------------------------------------------------------

\1\ Section 505-1 of the FD&C Act applies to applications for
prescription drugs submitted or approved under subsections 505(b)
(i.e., new drug applications) or (j) (i.e., abbreviated new drug
applications) of the FD&C Act and to applications submitted or
approved under section 351 (i.e., biologics license applications) of
the Public Health Service Act (42 U.S.C. 262). In this document,
unless otherwise specified, the term ``drug'' refers to drug and
biological products (or biologics).
---------------------------------------------------------------------------

FDA's determination as to whether a REMS is necessary for a
particular drug is a complex, drug-specific inquiry, reflecting an
analysis of multiple, interrelated factors. In conducting this
analysis, FDA considers whether (based on premarketing or postmarketing
risk assessments) there is a particular risk associated with the use of
the drug that, on balance, outweighs its benefits and whether
additional interventions beyond FDA-approved labeling are necessary to
ensure that the drug's benefits outweigh its risks.
If FDA determines that additional interventions are necessary to
ensure that the benefits of a drug outweigh its risks, FDA considers
what the goals of a proposed REMS to address these risks would be and
what specific elements could help meet those goals. If a REMS can be
designed that FDA expects will meet the relevant goals and not unduly
impede patient access to the drug, then FDA will generally approve the
drug with a REMS (or, if the drug is already being marketed, require
that a REMS be imposed for the drug). If FDA believes that the drug's
risks would exceed its benefits even if FDA were to require a REMS for
the drug, FDA will not approve the drug or may consider seeking
withdrawal of the drug if it is already being marketed.
FDAAA requires FDA to consider the following six factors \2\ in
making a

[[Page 64913]]

decision about whether to require a REMS:
---------------------------------------------------------------------------

\2\ Section 505-1(a)(1) of the FD&C Act requires the Agency to
consider these factors in determining whether a REMS is necessary
for a new drug. FDA also generally considers these factors in
determining whether (based on new safety information), a REMS is
necessary for a drug that is the subject of an approved application.
---------------------------------------------------------------------------

The seriousness of any known or potential adverse events
that may be related to the drug and the background incidence of such
events in the population likely to use the drug
The expected benefit of the drug with respect to the
disease or condition
The seriousness of the disease or condition that is to be
treated with the drug
Whether the drug is a new molecular entity
The expected or actual duration of treatment with the drug
The estimated size of the population likely to use the
drug

These six factors influence FDA's decisions with respect to both
whether a REMS is required for a particular drug and what type of REMS
might be necessary (i.e., what specific elements/tools should be
included as part of the REMS). FDA makes decisions about requiring a
REMS as part of a benefit-risk determination for a drug after an
evaluation that includes integrated consideration of each of the
statutory factors. No single factor, by itself, is determinative as to
whether a REMS is necessary to ensure that the benefits of a drug
outweigh its risks. This guidance describes how FDA considers each of
these factors in conducting its REMS analysis.
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 how the Agency
applies statutory factors in determining when a REMS is necessary. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22689 Filed 9-20-16; 8:45 am]
BILLING CODE 4164-01-P

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