Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 64299-64302 [2018-27098]
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Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules
said Order as hereby proposed to be
amended as follows:
The provisions of the proposed
marketing order amending the Order
contained in the proposed rule issued
by the Administrator on July 19, 2018,
and published in the Federal Register
(83 FR 34953) on July 24, 2018, will be
and are the terms and provisions of this
order amending the Order and are set
forth in full herein.
List of Subjects in 7 CFR Part 956
Onions, Marketing agreements,
Reporting and recordkeeping
requirements.
Dated: December 11, 2018.
Bruce Summers,
Administrator, Agricultural Marketing
Service.
For the reasons discussed in the
preamble, 7 CFR part 956 is proposed to
be amended as follows.
PART 956—SWEET ONIONS GROWN
IN THE WALLA WALLA VALLEY OF
SOUTHEAST WASHINGTON AND
NORTHEAST OREGON
1. The authority citation for 7 CFR
part 956 continues to read as follows:
■
until their successors are selected and
have qualified.
(b) The term of office of the initial
members and alternates shall begin as
soon as possible after the effective date
of this subpart. One-half of the initial
industry grower and handler members
and alternates shall serve for a one-year
term and one-half shall serve for a twoyear term. The initial as well as all
successive terms of office of the public
member and alternate member shall be
for three years.
(c) The consecutive terms of office for
all grower and handler members shall
be limited to two two-year terms. There
shall be no such limitation for alternate
members.
■ 4. Amend § 956.28 by revising
paragraph (a) to read as follows:
§ 956.28
Procedure.
(a) Four members of the Committee
shall constitute a quorum, and four
concurring votes shall be required to
pass any motion or approve any
Committee action, except that
recommendations made pursuant to
§ 956.61 shall require five concurring
votes.
*
*
*
*
*
[FR Doc. 2018–27143 Filed 12–13–18; 8:45 am]
Authority: 7 U.S.C. 601–674.
BILLING CODE 3410–02–P
2. Amend § 956.20 by revising
paragraph (a) to read as follows:
■
§ 956.20
DEPARTMENT OF COMMERCE
Establishment and membership.
(a) The Walla Walla Sweet Onion
Marketing Committee, consisting of
seven members, is hereby established.
The Committee shall consist of four
producer members, two handler
members, and one public member. Each
member shall have an alternate who
shall have the same qualifications as the
member.
*
*
*
*
*
■ 3. Revise § 956.21 to read as follows:
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§ 956.21
Term of office.
(a) Except as otherwise provided in
paragraph (b) of this section, the term of
office of grower and handler Committee
members and their respective alternates
shall be two fiscal periods beginning on
June 1 or such other date as
recommended by the Committee and
approved by the Secretary. The terms
shall be determined so that one-half of
the grower membership and one-half of
the handler membership shall terminate
each year. Members and alternates shall
serve during the term of office for which
they are selected and have been
qualified, or during that portion thereof
beginning on the date on which they
qualify during such term of office and
continuing until the end thereof, or
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Bureau of Industry and Security
15 CFR Part 744
[Docket No. 180712626–8840–01]
RIN 0694–AH61
Review of Controls for Certain
Emerging Technologies
Bureau of Industry and
Security, Commerce.
ACTION: Advance notice of proposed
rulemaking (ANPRM), Extension of
comment period.
AGENCY:
The Bureau of Industry and
Security (BIS) is extending the comment
period for its November 19, 2018,
advanced notice of proposed
rulemaking (ANPRM), ‘‘Review of
Controls for Certain Emerging
Technologies’’ until January 10, 2019. In
response to requests received from
members of the public, BIS believes it
is appropriate to extend the comment
period to provide interested parties
additional time to submit their
responses to the ANPRM.
DATES: The comment period announced
in the notice that was published on
November 19, 2018 (83 FR 58201) is
SUMMARY:
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extended. Comments on the ANPRM
must now be received by BIS on or
before January 10, 2019.
ADDRESSES: You may submit comments
through either of the following:
• Federal eRulemaking Portal: https://
www.regulations.gov. The identification
number for this rulemaking is BIS 2018–
0024.
• Address: By mail or delivery to
Regulatory Policy Division, Bureau of
Industry and Security, U.S. Department
of Commerce, Room 2099B, 14th Street
and Pennsylvania Avenue NW,
Washington, DC 20230. Refer to RIN
0694–AH61.
FOR FURTHER INFORMATION CONTACT:
Kirsten Mortimer, Office of National
Security and Technology Transfer
Controls, Bureau of Industry and
Security, Department of Commerce.
Phone: (202) 482–0092; Fax (202) 482–
3355; Email: Kirsten.Mortimer@
bis.doc.gov.
SUPPLEMENTARY INFORMATION:
Background
On November 19, 2018 (83 FR 58201),
the Bureau of Industry and Security
(BIS) published an advanced notice of
proposed rulemaking, ‘‘Review of
Controls for Certain Emerging
Technologies,’’ which included a
comment period deadline of December
19, 2018. Since publication, BIS has
received requests for additional time to
submit comments. In response to those
requests, BIS is extending the public
comment period until January 10, 2019.
A description of the specific topics and
issues that BIS would like addressed is
outlined in the November 19, 2018
Federal Register ANPRM.
Dated: December 10, 2018.
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
[FR Doc. 2018–27148 Filed 12–13–18; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 314 and 601
[Docket No. FDA–2013–N–0500]
Withdrawal of Proposed Rule on
Supplemental Applications Proposing
Labeling Changes for Approved Drugs
and Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Proposed Rules
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the withdrawal of the
proposed rule on ‘‘Supplemental
Applications Proposing Labeling
Changes for Approved Drugs and
Biological Products’’ that published in
the Federal Register of November 13,
2013. FDA is taking this action in light
of concerns expressed by commenters
and considerations regarding Agency
resources. FDA is continuing to
consider ways to improve the
communication of important, newly
acquired drug safety information to
healthcare providers and the public and
to facilitate efforts to keep drug product
labeling up to date throughout the
product lifecycle.
DATES: The proposed rule published
November 13, 2013 (78 FR 67985), is
withdrawn as of December 14, 2018.
ADDRESSES: For access to the docket, 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
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Janice L. Weiner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270,
Silver Spring, MD 20993–0002, 301–
796–3601, janice.weiner@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
Under the Federal Food, Drug, and
Cosmetic Act, the Public Health Service
Act, and FDA regulations, the Agency
makes decisions regarding the approval
of marketing applications, including
supplemental applications, based on a
comprehensive analysis of the product’s
risks and benefits under the conditions
of use prescribed, recommended, or
suggested in the labeling (see 21 U.S.C.
355(c) and (d); 42 U.S.C. 262). All drugs
have risks, and healthcare practitioners
and patients must balance the risks and
benefits of a drug when making
decisions about medical therapy. As a
drug is used more widely or under
diverse conditions, new information
regarding the risks and benefits of a
drug may become available, and may
include new risks or new information
about known risks. Accordingly, all
holders of new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), and biologics
license applications (BLAs) are required
to develop written procedures for the
surveillance, receipt, evaluation, and
reporting of postmarketing adverse drug
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experiences to FDA (see 21 CFR
314.80(b), 314.98(a), and 600.80(b)).
Application holders also must comply
with applicable reporting and
recordkeeping requirements, including
submission of an annual report (which
contains, among other things, a brief
summary of significant new information
from the previous year that might affect
the safety, effectiveness, or labeling of
the drug product, and a description of
the actions the applicant has taken or
intends to take as a result of this new
information) and, if appropriate,
proposed revisions to product labeling
(see 21 U.S.C. 355(k) and 21 CFR
314.81).
When new information becomes
available that causes labeling to be
inaccurate, false, or misleading, all drug
and biological product application
holders must take steps to change the
content of their product labeling in
accordance with §§ 314.70, 314.97, and
601.12 (21 CFR 314.70, 314.97, and
601.12) (see 21 CFR 201.56(a)(2); see
also 21 U.S.C. 331(a) and (b) and 352(a),
(f), and (j)). While all drug and
biological product application holders
have these obligations, under current
regulations, the procedures available to
ANDA holders to update the labeling of
generic drugs differ in certain respects
from the procedures available to NDA
holders and BLA holders to update
product labeling. In addition, there are
limitations on the procedures available
to NDA holders and BLA holders to
make certain updates to the Highlights
of Prescribing Information of drug and
biological product labeling that are
subject to the content and format
labeling requirements described in
§§ 201.56(d) and 201.57 (21 CFR
201.56(d) and 201.57) (commonly
referred to as the ‘‘Physician Labeling
Rule’’ (PLR) format).
In the Federal Register of November
13, 2013 (78 FR 67985), FDA proposed
to amend its regulations to revise and
clarify procedures for application
holders of an approved drug or
biological product to change the product
labeling to reflect certain types of newly
acquired safety-related information in
advance of FDA’s review of the change
by submitting a ‘‘changes being
effected’’ (CBE–0) supplement to FDA.
A CBE–0 supplement is an exception to
the general requirement for FDA
approval of a prior approval supplement
containing revised product labeling
before distribution. The proposed rule,
if finalized, would have enabled ANDA
holders for generic drugs to
independently update and promptly
distribute revised product labeling to
reflect certain types of newly acquired
safety-related information, even though
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the revised labeling may temporarily
differ from that of the corresponding
reference listed drug (RLD or brand
drug) upon submission of a CBE–0
supplement to FDA. FDA’s proposed
revisions to its regulations to allow
generic drug manufacturers to update
product labeling through CBE–0
supplements in the same manner as
brand drug manufacturers were
intended to improve communication of
important, newly acquired drug safety
information to healthcare providers and
the public. The proposed rule, if
finalized, also would have removed the
limitation on submission of CBE–0
supplements by any application holder
for certain changes to the Highlights of
Prescribing Information in PLR-format
product labeling. For further
information about these and other
proposed regulatory changes described
in the proposed rule, see 78 FR 67985.
FDA received numerous comments on
the proposed rule from a diverse group
of stakeholders. In view of requests to
meet with FDA to present alternatives to
the proposed regulatory changes
described in the proposed rule and to
promote transparency, FDA held a
public meeting on March 27, 2015, at
which any stakeholder had the
opportunity to present or comment on
the proposed rule or any alternative
proposals intended to improve
communication of important, newly
acquired drug safety information to
healthcare professionals and the public.
In the February 18, 2015, document
announcing the public meeting (80 FR
8577), FDA reopened the docket for the
proposed rule until April 27, 2015, to
receive submissions of additional
written comments on the proposed rule
as well as alternative proposals
presented during the public meeting.
Several comments supported
finalizing the rule as originally
proposed. Other comments supported
the goals of the proposed rule, but
expressed concern that temporary
labeling differences between generic
drugs and the corresponding brand drug
could complicate healthcare decision
making. Comments in support of the
proposed rule maintained that it would
enhance drug safety by making
healthcare practitioners and the public
aware of new safety-related information
about a drug more quickly. Several
comments also opined that tort liability
for failure to adequately warn patients
of a known hazard may be an incentive
for drug manufacturers to ensure that
their product labeling reflects the most
current safety information.
Comments in opposition to the
proposed rule raised policy, legal, and
cost considerations. A number of
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comments asserted that generic drug
application holders do not generally
receive or possess all the data necessary
to evaluate postmarket safety
information and to support safetyrelated labeling changes. Comments
expressed concern that additional or
different warnings in generic drug
labeling, even if temporary, may
undermine confidence in generic drugs
and their therapeutic equivalence to the
brand drug. Comments throughout the
healthcare delivery system also
expressed concern about the confusion
that might result if there were different
versions of safety labeling for multiple
generic versions of the same drug until
FDA decided whether to approve the
labeling changes proposed in the CBE–
0 supplements. Several comments
asserted that the proposed rule would
impose significant burdens on the
generic drug industry that would
necessarily increase the cost of generic
drugs or lead to market exit, which may
increase the risk of drug shortages.
However, most concerns regarding
economic impact focused on the
increased risk of tort litigation against
generic drug manufacturers and others
in the healthcare system.
II. Withdrawal of the Proposed Rule
Having reviewed the comments on the
proposed rule and further considered
the proposal, FDA is withdrawing the
proposed rule on ‘‘Supplemental
Applications Proposing Labeling
Changes for Approved Drugs and
Biological Products’’ published in the
Federal Register of November 13, 2013.
The concerns raised in the comments
reflect significant competing interests,
and FDA acknowledges that the
proposed rule, if finalized, would
present significant potential downsides.
In light of those potential downsides,
the Agency does not believe that
finalizing the proposed rule would be
an appropriate use of Agency resources.
Rather, the Agency believes that such
resources would be better used on other
efforts to improve the communication of
important, newly acquired drug safety
information to healthcare professionals
and the public, as discussed in greater
detail below.
The withdrawal of this proposed rule
does not alter the ongoing obligation
under FDA’s current regulations for all
holders of marketing applications for
drug and biological products—including
ANDA holders—to ensure their product
labeling is accurate, and not false or
misleading, and to take steps to update
their product labeling when new
information becomes available that
causes the labeling to become
inaccurate, false, or misleading (see
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§ 201.56(a)(2); see also 21 U.S.C. 331(a)
and (b) and 352(a), (f), and (j)). This
obligation serves an important public
health function because new
information regarding the risks and
benefits of a drug may become available
over time from various sources,
including from postmarketing adverse
drug experience reports and published
literature, and updates to product
labeling may be necessary.
In addition to the ongoing obligation
described above, ANDA holders must
generally maintain the same labeling as
the RLD throughout the lifecycle of the
generic drug product. ANDA holders
can, however, propose certain updates
to product labeling by submitting a prior
approval supplement that contains
adequate supporting information for the
proposed change. FDA will determine
whether the proposed labeling change is
appropriate, and whether the labeling
for the RLD and corresponding generic
drug(s) should be revised. If the
approval of the NDA for the RLD has
been withdrawn at the NDA holder’s
request because the RLD is no longer
being marketed and certain other
conditions are satisfied (see 21 CFR
314.150(c)), the NDA holder can no
longer update labeling for the
withdrawn RLD, but ANDA holders can
still propose labeling updates through
the submission of a prior approval
supplement. In such cases, if FDA
determines that the proposed labeling
change is appropriate and approves the
supplement, the Agency may request
that other ANDA holders and any
ANDA applicants relying on the same
withdrawn RLD make the same updates
(see FDA draft guidance for industry
‘‘Updating ANDA Labeling After the
Marketing Application for the Reference
Listed Drug Has Been Withdrawn,’’ 81
FR 44883, July 11, 2016) (Draft
Guidance on Updating ANDA Labeling)
(Ref. 1).
As noted, the proposed rule would
have removed the current prohibition
against the submission of CBE–0
supplements by NDA and BLA holders
to change information in the Highlights
of Prescribing Information portion of
drug labeling. If an NDA holder or a
BLA holder seeks to submit a CBE–0
supplement to change information in
the Highlights of Prescribing
Information to reflect newly acquired
information for any of the reasons
described in § 314.70(c)(6)(iii) or
§ 601.12(f)(2), as applicable, the NDA
holder or BLA holder can normally
obtain permission to do so under the
current regulation by contacting FDA. In
response to an applicant’s inquiry about
submission of a CBE–0 supplement for
a change that would affect the
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64301
Highlights of drug labeling, FDA
typically waives the limitation on
submission of a CBE–0 supplement
under 21 CFR 314.90 or specifically
requests that the applicant proceed with
a CBE–0 supplement under
§ 314.70(c)(6)(iii)(E) or
§ 601.12(f)(2)(i)(E).
FDA is continuing to consider ways to
improve the communication of
important, newly acquired drug safety
information to healthcare professionals
and the public, and to facilitate efforts
to keep drug product labeling up to date
throughout the product lifecycle.
Although the proposed rule focused on
labeling updates to reflect newly
acquired information related to drug
safety, we recognize that there are
general challenges for keeping generic
drug labeling up to date when the RLD
labeling is no longer being updated,
including when FDA has withdrawn
approval of the NDA for reasons other
than safety or effectiveness. The Agency
is actively evaluating ways to facilitate
the updating of generic drug labeling to
help ensure that drug labeling reflects
the most current information. For
example, FDA’s fiscal year (FY) 2019
Budget Request includes an investment
to support efforts to update generic drug
labeling, with an initial focus on
oncology products, as part of the
Agency’s efforts to ensure that patients
and their providers have access to upto-date information to inform clinical
decisions (Ref. 2). These efforts to
ensure that more generic drugs have upto-date product labeling reflecting the
latest treatment information can also
encourage wider adoption of generic
drugs, broadening access to lower-cost
alternatives to brand drugs for the
American people.
The withdrawal of this proposed rule
does not preclude the Agency from
reinstituting rulemaking concerning the
issues addressed in the proposal.
Should we decide to undertake such
rulemaking in the future, we will repropose the action and provide new
opportunities for comment.
Furthermore, this proposed rule is only
intended to address the withdrawal of
the proposed rule on ‘‘Supplemental
Applications Proposing Labeling
Changes for Approved Drugs and
Biological Products’’ published in the
Federal Register of November 13, 2013,
and not any other pending proposals
that the Agency has issued or is
considering, including the Draft
Guidance on Updating ANDA Labeling
(Ref. 1) or the Agency’s efforts to update
the labeling of certain oncology drug
products under FDA’s FY2019 Budget
Request (Ref. 2). If you need additional
information about the subject matter of
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the withdrawn proposed rule, you may
review the Agency’s website (https://
www.fda.gov) for any current
information on the matter.
III. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. FDA, draft guidance for industry,
‘‘Updating ANDA Labeling After the
Marketing Application for the Reference
Listed Drug Has Been Withdrawn,’’ July 2016
(available at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-drugs-gen/
documents/document/ucm510240.pdf).
2. U.S. Department of Health and Human
Services, Food and Drug Administration,
‘‘Fiscal Year 2019 Justification of Estimates
for Appropriations Committees’’ (available at
https://www.fda.gov/downloads/aboutfda/
reportsmanualstorms/reports/budgetreports/
ucm603315.pdf).
Dated: December 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27098 Filed 12–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No.: HHS–OCR–0945–AA00]
45 CFR Parts 160 and 164
RIN 0945–AA00
Request for Information on Modifying
HIPAA Rules To Improve Coordinated
Care
AGENCY:
Office for Civil Rights (OCR),
HHS.
ACTION:
Request for information.
The Office for Civil Rights
(OCR) is issuing this Request for
Information (RFI) to assist OCR in
identifying provisions of the Health
Insurance Portability and
Accountability Act privacy and security
regulations that may impede the
transformation to value-based health
care or that limit or discourage
coordinated care among individuals and
covered entities (including hospitals,
physicians, and other providers, payors,
and insurers), without meaningfully
contributing to the protection of the
privacy or security of individuals’
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SUMMARY:
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protected health information. This RFI
requests information on whether and
how the rules could be revised to
promote these goals, while preserving
and protecting the privacy and security
of such information and individuals’
rights with respect to it.
DATES: Comments must be submitted on
or before February 12, 2019.
ADDRESSES: You may send comments,
identified by RIN 0945–AA00 or Docket
HHS–OCR–0945–AA00, by any of the
following methods:
• Federal eRulemaking Portal. You
may submit electronic comments at
https://www.regulations.gov by searching
for the Docket ID number HHS–OCR–
0945–AA00. Follow the instructions for
sending comments.
• Hand-Delivery or Regular, Express,
or Overnight Mail: U.S. Department of
Health and Human Services, Office for
Civil Rights, Attention: RFI, RIN 0945–
AA00, Hubert H. Humphrey Building,
Room 509F, 200 Independence Avenue
SW, Washington, DC 20201.
Instructions: All submissions received
must include ‘‘Department of Health
and Human Services, Office for Civil
Rights RIN 0945–AA00’’ for this RFI. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided. Further
instructions are available under PUBLIC
PARTICIPATION.
Docket: For complete access to the
docket to read background documents
or comments received, go to https://
www.regulations.gov and search for
Docket ID number HHS–OCR–09454–
AA00.
FOR FURTHER INFORMATION CONTACT:
Marie Meszaros at (800) 368–1019 or
(800) 537–7697 (TDD).
SUPPLEMENTARY INFORMATION:
I. Background
This RFI seeks public input on the
regulations issued pursuant to the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA) 1
and modified pursuant to, among other
laws, the Health Information
Technology for Economic and Clinical
Health (HITECH) Act of 2009.2 The
HIPAA Privacy and Security Rules
protect individuals’ medical records and
1 See the Administrative Simplification
provisions of title II, subtitle F, of the HIPAA (Pub.
L. 104–191), which added a new part C to title XI
of the Social Security Act (sections 1171–1179 of
the Social Security Act, 42 U.S.C. 1320d–1320d–8)
and included section 264, under which HHS has
adopted the HIPAA Privacy Rule.
2 The HITECH Act was enacted as title XIII of
division A and title IV of division B of the
American Recovery and Reinvestment Act of 2009
(ARRA) (Pub. L. 111–5).
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other individually identifiable health
information created or received by or on
behalf of covered entities, known as
‘‘protected health information’’ (PHI).3
The Privacy and Security Rules limit the
circumstances under which covered
entities may use and disclose PHI and
require covered entities to implement
safeguards to protect the privacy and
security of PHI. The Privacy Rule also
gives individuals rights with respect to
their PHI, including the right to access
their PHI and to receive adequate notice
of a covered entity’s privacy practices.
In addition, the HIPAA Breach
Notification Rule requires HIPAA
covered entities to provide notification
following a breach of unsecured PHI to
individuals and OCR (and, in some
instances, the media) and requires
business associates to notify the relevant
covered entities of such breaches.4 In
this RFI, the Privacy, Security, and
Breach Notification Rules will be
referenced collectively as the HIPAA
Rules.
OCR seeks public input on ways to
modify the HIPAA Rules to remove
regulatory obstacles and decrease
regulatory burdens in order to facilitate
efficient care coordination and/or case
management and to promote the
transformation to value-based health
care, while preserving the privacy and
security of PHI. Specifically, OCR seeks
information on the provisions of the
HIPAA Rules that may present obstacles
to, or place unnecessary burdens on, the
ability of covered entities and business
associates to conduct care coordination
and/or case management, or that may
inhibit the transformation of the health
care system to a value-based health care
system. Correspondingly, OCR seeks
comment on modifications to the
HIPAA Rules that would facilitate
efficient care coordination and/or case
management, and/or promote the
transformation to value-based health
care. OCR also broadly requests
information and perspectives from
regulated entities and the public about
covered entities’ and business
associates’ technical capabilities,
individuals’ interests, and ways to
achieve these goals.
In addition, OCR seeks comment on
aspects of the Privacy Rule that OCR has
identified for potential modification to
further these goals, specifically:
• Promoting information sharing for
treatment and care coordination and/or
case management by amending the
Privacy Rule to encourage, incentivize,
3 See the HIPAA Privacy and Security Rules at 45
CFR part 160 and Subparts A, C, and E of part 164.
4 See 45 CFR part 160 and part 164, Subparts A
and D.
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]]>Agencies
[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)]
[Proposed Rules]
[Pages 64299-64302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27098]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 314 and 601
[Docket No. FDA-2013-N-0500]
Withdrawal of Proposed Rule on Supplemental Applications
Proposing Labeling Changes for Approved Drugs and Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the withdrawal of the proposed rule on ``Supplemental
Applications Proposing Labeling Changes for Approved Drugs and
Biological Products'' that published in the Federal Register of
November 13, 2013. FDA is taking this action in light of concerns
expressed by commenters and considerations regarding Agency resources.
FDA is continuing to consider ways to improve the communication of
important, newly acquired drug safety information to healthcare
providers and the public and to facilitate efforts to keep drug product
labeling up to date throughout the product lifecycle.
DATES: The proposed rule published November 13, 2013 (78 FR 67985), is
withdrawn as of December 14, 2018.
ADDRESSES: For access to the docket, 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Janice L. Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-
796-3601, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under the Federal Food, Drug, and Cosmetic Act, the Public Health
Service Act, and FDA regulations, the Agency makes decisions regarding
the approval of marketing applications, including supplemental
applications, based on a comprehensive analysis of the product's risks
and benefits under the conditions of use prescribed, recommended, or
suggested in the labeling (see 21 U.S.C. 355(c) and (d); 42 U.S.C.
262). All drugs have risks, and healthcare practitioners and patients
must balance the risks and benefits of a drug when making decisions
about medical therapy. As a drug is used more widely or under diverse
conditions, new information regarding the risks and benefits of a drug
may become available, and may include new risks or new information
about known risks. Accordingly, all holders of new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and biologics
license applications (BLAs) are required to develop written procedures
for the surveillance, receipt, evaluation, and reporting of
postmarketing adverse drug experiences to FDA (see 21 CFR 314.80(b),
314.98(a), and 600.80(b)). Application holders also must comply with
applicable reporting and recordkeeping requirements, including
submission of an annual report (which contains, among other things, a
brief summary of significant new information from the previous year
that might affect the safety, effectiveness, or labeling of the drug
product, and a description of the actions the applicant has taken or
intends to take as a result of this new information) and, if
appropriate, proposed revisions to product labeling (see 21 U.S.C.
355(k) and 21 CFR 314.81).
When new information becomes available that causes labeling to be
inaccurate, false, or misleading, all drug and biological product
application holders must take steps to change the content of their
product labeling in accordance with Sec. Sec. 314.70, 314.97, and
601.12 (21 CFR 314.70, 314.97, and 601.12) (see 21 CFR 201.56(a)(2);
see also 21 U.S.C. 331(a) and (b) and 352(a), (f), and (j)). While all
drug and biological product application holders have these obligations,
under current regulations, the procedures available to ANDA holders to
update the labeling of generic drugs differ in certain respects from
the procedures available to NDA holders and BLA holders to update
product labeling. In addition, there are limitations on the procedures
available to NDA holders and BLA holders to make certain updates to the
Highlights of Prescribing Information of drug and biological product
labeling that are subject to the content and format labeling
requirements described in Sec. Sec. 201.56(d) and 201.57 (21 CFR
201.56(d) and 201.57) (commonly referred to as the ``Physician Labeling
Rule'' (PLR) format).
In the Federal Register of November 13, 2013 (78 FR 67985), FDA
proposed to amend its regulations to revise and clarify procedures for
application holders of an approved drug or biological product to change
the product labeling to reflect certain types of newly acquired safety-
related information in advance of FDA's review of the change by
submitting a ``changes being effected'' (CBE-0) supplement to FDA. A
CBE-0 supplement is an exception to the general requirement for FDA
approval of a prior approval supplement containing revised product
labeling before distribution. The proposed rule, if finalized, would
have enabled ANDA holders for generic drugs to independently update and
promptly distribute revised product labeling to reflect certain types
of newly acquired safety-related information, even though the revised
labeling may temporarily differ from that of the corresponding
reference listed drug (RLD or brand drug) upon submission of a CBE-0
supplement to FDA. FDA's proposed revisions to its regulations to allow
generic drug manufacturers to update product labeling through CBE-0
supplements in the same manner as brand drug manufacturers were
intended to improve communication of important, newly acquired drug
safety information to healthcare providers and the public. The proposed
rule, if finalized, also would have removed the limitation on
submission of CBE-0 supplements by any application holder for certain
changes to the Highlights of Prescribing Information in PLR-format
product labeling. For further information about these and other
proposed regulatory changes described in the proposed rule, see 78 FR
67985.
FDA received numerous comments on the proposed rule from a diverse
group of stakeholders. In view of requests to meet with FDA to present
alternatives to the proposed regulatory changes described in the
proposed rule and to promote transparency, FDA held a public meeting on
March 27, 2015, at which any stakeholder had the opportunity to present
or comment on the proposed rule or any alternative proposals intended
to improve communication of important, newly acquired drug safety
information to healthcare professionals and the public. In the February
18, 2015, document announcing the public meeting (80 FR 8577), FDA
reopened the docket for the proposed rule until April 27, 2015, to
receive submissions of additional written comments on the proposed rule
as well as alternative proposals presented during the public meeting.
Several comments supported finalizing the rule as originally
proposed. Other comments supported the goals of the proposed rule, but
expressed concern that temporary labeling differences between generic
drugs and the corresponding brand drug could complicate healthcare
decision making. Comments in support of the proposed rule maintained
that it would enhance drug safety by making healthcare practitioners
and the public aware of new safety-related information about a drug
more quickly. Several comments also opined that tort liability for
failure to adequately warn patients of a known hazard may be an
incentive for drug manufacturers to ensure that their product labeling
reflects the most current safety information.
Comments in opposition to the proposed rule raised policy, legal,
and cost considerations. A number of
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comments asserted that generic drug application holders do not
generally receive or possess all the data necessary to evaluate
postmarket safety information and to support safety-related labeling
changes. Comments expressed concern that additional or different
warnings in generic drug labeling, even if temporary, may undermine
confidence in generic drugs and their therapeutic equivalence to the
brand drug. Comments throughout the healthcare delivery system also
expressed concern about the confusion that might result if there were
different versions of safety labeling for multiple generic versions of
the same drug until FDA decided whether to approve the labeling changes
proposed in the CBE-0 supplements. Several comments asserted that the
proposed rule would impose significant burdens on the generic drug
industry that would necessarily increase the cost of generic drugs or
lead to market exit, which may increase the risk of drug shortages.
However, most concerns regarding economic impact focused on the
increased risk of tort litigation against generic drug manufacturers
and others in the healthcare system.
II. Withdrawal of the Proposed Rule
Having reviewed the comments on the proposed rule and further
considered the proposal, FDA is withdrawing the proposed rule on
``Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products'' published in the Federal Register of
November 13, 2013. The concerns raised in the comments reflect
significant competing interests, and FDA acknowledges that the proposed
rule, if finalized, would present significant potential downsides. In
light of those potential downsides, the Agency does not believe that
finalizing the proposed rule would be an appropriate use of Agency
resources. Rather, the Agency believes that such resources would be
better used on other efforts to improve the communication of important,
newly acquired drug safety information to healthcare professionals and
the public, as discussed in greater detail below.
The withdrawal of this proposed rule does not alter the ongoing
obligation under FDA's current regulations for all holders of marketing
applications for drug and biological products--including ANDA holders--
to ensure their product labeling is accurate, and not false or
misleading, and to take steps to update their product labeling when new
information becomes available that causes the labeling to become
inaccurate, false, or misleading (see Sec. 201.56(a)(2); see also 21
U.S.C. 331(a) and (b) and 352(a), (f), and (j)). This obligation serves
an important public health function because new information regarding
the risks and benefits of a drug may become available over time from
various sources, including from postmarketing adverse drug experience
reports and published literature, and updates to product labeling may
be necessary.
In addition to the ongoing obligation described above, ANDA holders
must generally maintain the same labeling as the RLD throughout the
lifecycle of the generic drug product. ANDA holders can, however,
propose certain updates to product labeling by submitting a prior
approval supplement that contains adequate supporting information for
the proposed change. FDA will determine whether the proposed labeling
change is appropriate, and whether the labeling for the RLD and
corresponding generic drug(s) should be revised. If the approval of the
NDA for the RLD has been withdrawn at the NDA holder's request because
the RLD is no longer being marketed and certain other conditions are
satisfied (see 21 CFR 314.150(c)), the NDA holder can no longer update
labeling for the withdrawn RLD, but ANDA holders can still propose
labeling updates through the submission of a prior approval supplement.
In such cases, if FDA determines that the proposed labeling change is
appropriate and approves the supplement, the Agency may request that
other ANDA holders and any ANDA applicants relying on the same
withdrawn RLD make the same updates (see FDA draft guidance for
industry ``Updating ANDA Labeling After the Marketing Application for
the Reference Listed Drug Has Been Withdrawn,'' 81 FR 44883, July 11,
2016) (Draft Guidance on Updating ANDA Labeling) (Ref. 1).
As noted, the proposed rule would have removed the current
prohibition against the submission of CBE-0 supplements by NDA and BLA
holders to change information in the Highlights of Prescribing
Information portion of drug labeling. If an NDA holder or a BLA holder
seeks to submit a CBE-0 supplement to change information in the
Highlights of Prescribing Information to reflect newly acquired
information for any of the reasons described in Sec. 314.70(c)(6)(iii)
or Sec. 601.12(f)(2), as applicable, the NDA holder or BLA holder can
normally obtain permission to do so under the current regulation by
contacting FDA. In response to an applicant's inquiry about submission
of a CBE-0 supplement for a change that would affect the Highlights of
drug labeling, FDA typically waives the limitation on submission of a
CBE-0 supplement under 21 CFR 314.90 or specifically requests that the
applicant proceed with a CBE-0 supplement under Sec.
314.70(c)(6)(iii)(E) or Sec. 601.12(f)(2)(i)(E).
FDA is continuing to consider ways to improve the communication of
important, newly acquired drug safety information to healthcare
professionals and the public, and to facilitate efforts to keep drug
product labeling up to date throughout the product lifecycle. Although
the proposed rule focused on labeling updates to reflect newly acquired
information related to drug safety, we recognize that there are general
challenges for keeping generic drug labeling up to date when the RLD
labeling is no longer being updated, including when FDA has withdrawn
approval of the NDA for reasons other than safety or effectiveness. The
Agency is actively evaluating ways to facilitate the updating of
generic drug labeling to help ensure that drug labeling reflects the
most current information. For example, FDA's fiscal year (FY) 2019
Budget Request includes an investment to support efforts to update
generic drug labeling, with an initial focus on oncology products, as
part of the Agency's efforts to ensure that patients and their
providers have access to up-to-date information to inform clinical
decisions (Ref. 2). These efforts to ensure that more generic drugs
have up-to-date product labeling reflecting the latest treatment
information can also encourage wider adoption of generic drugs,
broadening access to lower-cost alternatives to brand drugs for the
American people.
The withdrawal of this proposed rule does not preclude the Agency
from reinstituting rulemaking concerning the issues addressed in the
proposal. Should we decide to undertake such rulemaking in the future,
we will re-propose the action and provide new opportunities for
comment. Furthermore, this proposed rule is only intended to address
the withdrawal of the proposed rule on ``Supplemental Applications
Proposing Labeling Changes for Approved Drugs and Biological Products''
published in the Federal Register of November 13, 2013, and not any
other pending proposals that the Agency has issued or is considering,
including the Draft Guidance on Updating ANDA Labeling (Ref. 1) or the
Agency's efforts to update the labeling of certain oncology drug
products under FDA's FY2019 Budget Request (Ref. 2). If you need
additional information about the subject matter of
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the withdrawn proposed rule, you may review the Agency's website
(https://www.fda.gov) for any current information on the matter.
III. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. FDA, draft guidance for industry, ``Updating ANDA Labeling
After the Marketing Application for the Reference Listed Drug Has
Been Withdrawn,'' July 2016 (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm510240.pdf).
2. U.S. Department of Health and Human Services, Food and Drug
Administration, ``Fiscal Year 2019 Justification of Estimates for
Appropriations Committees'' (available at https://www.fda.gov/downloads/aboutfda/reportsmanualstorms/reports/budgetreports/ucm603315.pdf).
Dated: December 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27098 Filed 12-13-18; 8:45 am]
BILLING CODE 4164-01-P
