Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability, 21297-21299 [2018-09843]
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Federal Register / Vol. 83, No. 90 / Wednesday, May 9, 2018 / Notices
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
amozie on DSK3GDR082PROD with NOTICES
CMS–10102 National Implementation
of the Hospital CAHPS Survey
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: National
Implementation of the Hospital CAHPS
Survey; Use: The HCAHPS (Hospital
Consumer Assessment of Healthcare
Providers and Systems) Survey, also
known as the CAHPS® Hospital Survey
or Hospital CAHPS®, is a standardized
survey instrument and data collection
methodology that has been in use since
2006 to measure patients’ perspectives
of hospital care. While many hospitals
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collect information on patient
satisfaction, HCAHPS created a national
standard for the collection and public
reporting of information that enables
valid comparisons to be made across all
hospitals to support consumer choice.
Form Number: CMS–10102 (OMB
control number 0938–0981); Frequency:
Occasionally; Affected Public: Private
sector (Business or other for-profits and
Not-for-profit institutions); Number of
Respondents: 4,200; Total Annual
Responses: 3,100,000; Total Annual
Hours: 413,230. (For policy questions
regarding this collection contact
William Lehrman at 410–786–1037.)
Dated: May 2, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–09686 Filed 5–8–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1434]
Waivers, Exceptions, and Exemptions
From the Requirements of Section 582
of the Federal Food, Drug, and
Cosmetic Act; 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 ‘‘Waivers,
Exceptions, and Exemptions from the
Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act.’’
When finalized, this draft guidance will
describe the process that trading
partners and stakeholders should use to
request a waiver, exception, or
exemption from certain requirements of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act), and describe how FDA
intends to review and decide such
requests and determine FDA-initiated
exceptions and exemptions.
Additionally, when finalized, this draft
guidance will describe how FDA
intends to biennially review and renew
waivers, exceptions, and exemptions.
DATES: Submit either electronic or
written comments on the draft guidance
by July 9, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
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21297
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–D–1434 for ‘‘Waivers, Exceptions,
and Exemptions from the Requirements
of Section 582 of the Federal Food,
Drug, and Cosmetic Act; 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
Dockets Management Staff 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
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09MYN1
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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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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 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 that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Abha Kundi, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
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17:39 May 08, 2018
Jkt 244001
Ave., Silver Spring, MD 20993–0002,
301–796–3130, drugtrackandtrace@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Waivers, Exceptions, and Exemptions
from the Requirements of Section 582 of
the Federal Food, Drug, and Cosmetic
Act.’’ The Drug Supply Chain Security
Act (DSCSA) was signed into law on
November 27, 2013 (Title II of Pub. L.
113–54). The DSCSA outlines critical
steps to build an electronic,
interoperable system by 2023 that can
identify and trace products as they are
distributed in the United States. Section
202 of the DSCSA added section 582 to
the FD&C Act (21 U.S.C. 360eee-1),
which sets forth trading partner
requirements, including those related to
product tracing, product identifiers,
authorized trading partners, and
verification. Section 582(a)(3)(A) of the
FD&C Act directs FDA to establish
processes by which: (1) An authorized
trading partner (i.e., manufacturer,
repackager, wholesale distributor, or
dispenser) may request a waiver from
certain requirements in section 582 if it
would result in an undue economic
hardship or for emergency medical
reasons; (2) a manufacturer or
repackager may request an exception to
the section 582 requirements related to
product identifiers if a product package
is too small or otherwise unable to
accommodate a label with sufficient
space; and (3) FDA may determine other
products or transactions shall be exempt
from certain requirements in section
582.
Accordingly, this draft guidance
describes these processes required by
the law. Additionally, as required by
section 582(a)(3)(B) of the FD&C Act,
this draft guidance also includes a
process for the biennial review and
renewal of waivers, exceptions, and
exemptions.
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 the process for waivers, exceptions,
and exemptions from the requirements
of section 582 of the FD&C Act. 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. This
guidance is not subject to Executive
Order 12866.
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Fmt 4703
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II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3520),
Federal Agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
III. Waivers, Exceptions, and
Exemptions From the Requirements of
Section 582 of the FD&C Act
Under the draft guidance, a trading
partner or stakeholder may request a
waiver, exception, or exemption from
the requirements of section 582 of the
FD&C Act. FDA estimates that annually
a total of approximately 20 waiver,
exception, or exemption requests will be
submitted to the Agency by
approximately 20 trading partners or
stakeholders. This estimate is based on
communications the Agency has had
with trading partners and stakeholders
since the enactment of the DSCSA in
2013. FDA also estimates that it will
take respondents an average of 40 hours
to prepare and submit each request,
including the time to submit any
additional followup information that
may be requested by FDA. FDA
estimates that the total annual burden
hours for submitting these requests are
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approximately 800 hours (see table 1,
row 1).
Under the draft guidance, a recipient
of a waiver, exception, or exemption
should notify FDA whenever there is a
material change in the circumstances
that were the basis for the relief. In
addition, FDA intends to biennially
review waivers, exceptions, and
exemptions that are longer than 2 years
in duration as described in the draft
guidance, and may ask the recipients to
submit information to determine
whether there has been a material
change in the circumstances.
FDA estimates that annually it will
receive approximately 1 notification or
other information from approximately 1
respondent that there has or has not
been a material change in the
circumstances that warranted the
waiver, exception, or exemption, and
that each notification will take
approximately 16 hours to prepare and
submit to FDA. We estimate that the
total annual burden hours for
submitting this information to FDA are
approximately 16 hours (see table 1, row
2).
Under the draft guidance, a trading
partner may request that FDA renew a
waiver, exception, or exemption that is
of limited duration. This request should
include a detailed statement justifying
the continuance of the relief and the
desired length of the extension. FDA
estimates that annually it will receive
approximately 1 renewal request from
approximately 1 respondent, and that
each request will take approximately 16
hours to prepare and submit to FDA. We
estimate that the total annual burden
hours for submitting these requests to
FDA are approximately 16 hours (see
table 1, row 3).
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Waivers, Exceptions, and Exemptions from section 582 of
the FD&C Act—Draft Guidance
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Requests to FDA for a Waiver, Exception, or Exemption ...
Notification to FDA of a Material Change in Circumstances
Warranting the Waiver, Exception, or Exemption ............
Requests to FDA to Renew a Waiver, Exception, or Exemption .............................................................................
20
1
20
40
800
1
1
1
16
16
1
1
1
16
16
Total ..............................................................................
........................
........................
........................
........................
832
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: May 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–09843 Filed 5–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
amozie on DSK3GDR082PROD with NOTICES
National Advisory Council on the
National Health Service Corps; Notice
of Meeting
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Advisory Committee
meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
SUMMARY:
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17:39 May 08, 2018
Jkt 244001
notice announces that the National
Advisory Council of the National Health
Service Corps (NACNHSC) will hold a
public meeting.
DATES: Tuesday, May 15, 2018, 2:00
p.m. to 5:30 p.m. ET.
ADDRESSES: The meeting is a
teleconference and webinar. The
conference call-in number is 1–800–
619–2521; passcode: 9271697. The
webinar link is https://
hrsa.connectsolutions.com/nacnhsc.
FOR FURTHER INFORMATION CONTACT:
Diane Fabiyi-King, Designated Federal
Official (DFO), Division of National
Health Service Corps (NHSC), Bureau of
Health Workforce (BHW), HRSA.
Address: 5600 Fishers Lane, Room
14N110, Rockville, Maryland 20857;
phone: (301) 443–3609; or email:
DFabiyi-King@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Background: NACNHSC consults,
advises, and makes recommendations to
the Secretary of HHS and HRSA’s
Administrator, with respect to their
responsibilities under Subpart II, Part D
of Title III of the Public Health Service
Act, as amended (NHSC and Health
Professional Shortage Area
Designations). The NACNHSC also
reviews and comments on regulations
promulgated by the Secretary under
Subpart II.
Agenda: During the May 15, 2018,
meeting, NACNHSC will discuss issues
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related to current focus areas of the
NHSC. Information about the
NACNHSC, a roster of members, the
meeting agenda, as well as past meeting
summaries is located on the NACNHSC
website: https://nhsc.hrsa.gov/
corpsexperience/aboutus/
nationaladvisorycouncil/.
Public Participation: Members of the
public and interested parties may
request to participate in the meeting or
provide oral public comment during the
meeting by contacting Monica-Tia
Bullock via email at MBullock@hrsa.gov
by May 10, 2018. Public comment will
be limited to three (3) minutes per
speaker.
Public participants may also submit
written statements in advance of the
scheduled meeting. Written statements
are due to Monica-Tia Bullock at
MBullock@hrsa.gov by May 10, 2018.
Please be advised that committee
members will receive copies of all
written statements submitted from the
public. Any further public participation
will be at the sole discretion of the
Chair, with approval from the DFO.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–09825 Filed 5–8–18; 8:45 am]
BILLING CODE 4165–15–P
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]]>Agencies
[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)]
[Notices]
[Pages 21297-21299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09843]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1434]
Waivers, Exceptions, and Exemptions From the Requirements of
Section 582 of the Federal Food, Drug, and Cosmetic Act; 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 ``Waivers,
Exceptions, and Exemptions from the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act.'' When finalized, this draft
guidance will describe the process that trading partners and
stakeholders should use to request a waiver, exception, or exemption
from certain requirements of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), and describe how FDA intends to review and decide such
requests and determine FDA-initiated exceptions and exemptions.
Additionally, when finalized, this draft guidance will describe how FDA
intends to biennially review and renew waivers, exceptions, and
exemptions.
DATES: Submit either electronic or written comments on the draft
guidance by July 9, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-D-1434 for ``Waivers, Exceptions, and Exemptions from the
Requirements of Section 582 of the Federal Food, Drug, and Cosmetic
Act; 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 Dockets Management Staff 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
[[Page 21298]]
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 Dockets Management
Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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 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 that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Abha Kundi, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Waivers, Exceptions, and Exemptions from the Requirements of
Section 582 of the Federal Food, Drug, and Cosmetic Act.'' The Drug
Supply Chain Security Act (DSCSA) was signed into law on November 27,
2013 (Title II of Pub. L. 113-54). The DSCSA outlines critical steps to
build an electronic, interoperable system by 2023 that can identify and
trace products as they are distributed in the United States. Section
202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-
1), which sets forth trading partner requirements, including those
related to product tracing, product identifiers, authorized trading
partners, and verification. Section 582(a)(3)(A) of the FD&C Act
directs FDA to establish processes by which: (1) An authorized trading
partner (i.e., manufacturer, repackager, wholesale distributor, or
dispenser) may request a waiver from certain requirements in section
582 if it would result in an undue economic hardship or for emergency
medical reasons; (2) a manufacturer or repackager may request an
exception to the section 582 requirements related to product
identifiers if a product package is too small or otherwise unable to
accommodate a label with sufficient space; and (3) FDA may determine
other products or transactions shall be exempt from certain
requirements in section 582.
Accordingly, this draft guidance describes these processes required
by the law. Additionally, as required by section 582(a)(3)(B) of the
FD&C Act, this draft guidance also includes a process for the biennial
review and renewal of waivers, exceptions, and exemptions.
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 the process
for waivers, exceptions, and exemptions from the requirements of
section 582 of the FD&C Act. 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. This guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
III. Waivers, Exceptions, and Exemptions From the Requirements of
Section 582 of the FD&C Act
Under the draft guidance, a trading partner or stakeholder may
request a waiver, exception, or exemption from the requirements of
section 582 of the FD&C Act. FDA estimates that annually a total of
approximately 20 waiver, exception, or exemption requests will be
submitted to the Agency by approximately 20 trading partners or
stakeholders. This estimate is based on communications the Agency has
had with trading partners and stakeholders since the enactment of the
DSCSA in 2013. FDA also estimates that it will take respondents an
average of 40 hours to prepare and submit each request, including the
time to submit any additional followup information that may be
requested by FDA. FDA estimates that the total annual burden hours for
submitting these requests are
[[Page 21299]]
approximately 800 hours (see table 1, row 1).
Under the draft guidance, a recipient of a waiver, exception, or
exemption should notify FDA whenever there is a material change in the
circumstances that were the basis for the relief. In addition, FDA
intends to biennially review waivers, exceptions, and exemptions that
are longer than 2 years in duration as described in the draft guidance,
and may ask the recipients to submit information to determine whether
there has been a material change in the circumstances.
FDA estimates that annually it will receive approximately 1
notification or other information from approximately 1 respondent that
there has or has not been a material change in the circumstances that
warranted the waiver, exception, or exemption, and that each
notification will take approximately 16 hours to prepare and submit to
FDA. We estimate that the total annual burden hours for submitting this
information to FDA are approximately 16 hours (see table 1, row 2).
Under the draft guidance, a trading partner may request that FDA
renew a waiver, exception, or exemption that is of limited duration.
This request should include a detailed statement justifying the
continuance of the relief and the desired length of the extension. FDA
estimates that annually it will receive approximately 1 renewal request
from approximately 1 respondent, and that each request will take
approximately 16 hours to prepare and submit to FDA. We estimate that
the total annual burden hours for submitting these requests to FDA are
approximately 16 hours (see table 1, row 3).
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Waivers, Exceptions, and Number of
Exemptions from section 582 of Number of responses per Total annual Average burden Total hours
the FD&C Act--Draft Guidance respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Requests to FDA for a Waiver, 20 1 20 40 800
Exception, or Exemption........
Notification to FDA of a 1 1 1 16 16
Material Change in
Circumstances Warranting the
Waiver, Exception, or Exemption
Requests to FDA to Renew a 1 1 1 16 16
Waiver, Exception, or Exemption
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 832
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: May 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09843 Filed 5-8-18; 8:45 am]
BILLING CODE 4164-01-P
