Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products, 13822-13823 [2017-05100]
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13822
Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0719]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Planning for the Effects of
High Absenteeism To Ensure
Availability of Medically Necessary
Drug Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Fax written comments on the
collection of information by April 14,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0675. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
SUMMARY:
Guidance for Industry on Planning for
the Effects of High Absenteeism To
Ensure Availability of Medically
Necessary Drug Products OMB Control
Number 0910–0675—Extension
The guidance recommends that
manufacturers of drug and therapeutic
biological products and manufacturers
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
of raw materials and components used
in those products develop a written
Emergency Plan (Plan) for maintaining
an adequate supply of medically
necessary drug products (MNPs) during
an emergency that results in high
employee absenteeism. The guidance
discusses the issues that should be
covered by the Plan, such as: (1)
Identifying a person or position title (as
well as two designated alternates) with
the authority to activate and deactivate
the Plan and make decisions during the
emergency; (2) prioritizing the
manufacturer’s drug products based on
medical necessity; (3) identifying
actions that should be taken prior to an
anticipated period of high absenteeism;
(4) identifying criteria for activating the
Plan; (5) performing quality risk
assessments to determine which
manufacturing activities may be
reduced to enable the company to meet
a demand for MNPs; (6) returning to
normal operations and conducting a
post-execution assessment of the
execution outcomes; and (7) testing the
Plan. The guidance recommends
developing a Plan for each individual
manufacturing facility as well as a
broader Plan that addresses multiple
sites within the organization. For
purposes of this information collection
analysis, we consider the Plan for an
individual manufacturing facility as
well as the broader Plan to comprise one
Plan for each manufacturer. Based on
FDA’s data on the number of
manufacturers that would be covered by
the guidance, we estimate that
approximately 70 manufacturers will
develop a Plan as recommended by the
guidance (i.e., one Plan per
manufacturer to include all
manufacturing facilities, sites, and drug
products), and that each Plan will take
approximately 500 hours to develop,
maintain, and update.
The guidance also encourages
manufacturers to include a procedure in
their Plan for notifying the Center for
Drug Evaluation and Research (CDER)
when the Plan is activated and when
returning to normal operations. The
guidance recommends that these
notifications occur within 1 day of a
Plan’s activation and within 1 day of a
Plan’s deactivation. The guidance
specifies the information that should be
included in these notifications, such as
which drug products will be
manufactured under altered procedures,
which products will have
manufacturing temporarily delayed, and
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
any anticipated or potential drug
shortages. We expect that approximately
two notifications (for purposes of this
analysis, we consider an activation and
a deactivation notification to equal one
notification) will be sent to CDER by
approximately two manufacturers each
year, and that each notification will take
approximately 16 hours to prepare and
submit.
The guidance also refers to previously
approved collections of information
found in FDA regulations. Under the
guidance, if a manufacturer obtains
information after releasing an MNP
under its Plan leading to suspicion that
the product might be defective, CDER
should be contacted immediately at
drugshortages@fda.hhs.gov in
adherence to existing recall reporting
regulations (21 CFR 7.40) (OMB control
number 0910–0249), or defect reporting
requirements for drug application
products (21 CFR 314.81(b)(1)) and
therapeutic biological products
regulated by CDER (21 CFR 600.14)
(OMB control numbers 0910–0001 and
0910–0458, respectively).
In addition, the following collections
of information found in FDA current
good manufacturing practice (CGMP)
regulations in part 211 (21 CFR part
211) are approved under OMB control
number 0190–0139. The guidance
encourages manufacturers to maintain
records, in accordance with the CGMP
requirements (see, e.g., § 211.180) that
support decisions to carry out changes
to approved procedures for
manufacturing and release of products
under the Plan. The guidance states that
a Plan should be developed, written,
reviewed, and approved within the
site’s change control quality system in
accordance with the requirements in
§§ 211.100(a) and 211.160(a); execution
of the Plan should be documented in
accordance with the requirements
described in § 211.100(b); and standard
operating procedures should be
reviewed and revised or supplementary
procedures developed and approved to
enable execution of the Plan.
In the Federal Register of November
3, 2016 (81 FR 76618), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. No
comments were received in response to
the notice.
We estimate the burden of this
information collection as follows:
E:\FR\FM\15MRN1.SGM
15MRN1
Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
13823
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Absenteeism guidance
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Notify FDA of Plan Activation and Deactivation ............................................
2
1
2
16
32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Absenteeism guidance
Number of
recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Develop Initial Plan ................................
70
1
70
500
35,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05100 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1063]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Oncologic Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
DATES: The meeting will be held on
March 29, 2017, from 8 a.m. to 5 p.m.
Submit either electronic or written
comments on this document by March
28, 2017. Late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before March 28, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
March 28, 2017. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
SUMMARY:
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
Sheraton College Park North
Hotel, Chesapeake Ballroom, 4095
Powder Mill Road, Beltsville, MD
20705. The hotel’s telephone number is
301–937–4422. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
You may submit comments 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’’).
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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–
2017–N–1063 for ‘‘Oncologic Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see DATES), 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
E:\FR\FM\15MRN1.SGM
15MRN1
Agencies
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13822-13823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05100]
[[Page 13822]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0719]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Planning for the Effects of High Absenteeism To Ensure Availability
of Medically Necessary Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (PRA).
DATES: Fax written comments on the collection of information by April
14, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0675.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Planning for the Effects of High Absenteeism
To Ensure Availability of Medically Necessary Drug Products OMB Control
Number 0910-0675--Extension
The guidance recommends that manufacturers of drug and therapeutic
biological products and manufacturers of raw materials and components
used in those products develop a written Emergency Plan (Plan) for
maintaining an adequate supply of medically necessary drug products
(MNPs) during an emergency that results in high employee absenteeism.
The guidance discusses the issues that should be covered by the Plan,
such as: (1) Identifying a person or position title (as well as two
designated alternates) with the authority to activate and deactivate
the Plan and make decisions during the emergency; (2) prioritizing the
manufacturer's drug products based on medical necessity; (3)
identifying actions that should be taken prior to an anticipated period
of high absenteeism; (4) identifying criteria for activating the Plan;
(5) performing quality risk assessments to determine which
manufacturing activities may be reduced to enable the company to meet a
demand for MNPs; (6) returning to normal operations and conducting a
post-execution assessment of the execution outcomes; and (7) testing
the Plan. The guidance recommends developing a Plan for each individual
manufacturing facility as well as a broader Plan that addresses
multiple sites within the organization. For purposes of this
information collection analysis, we consider the Plan for an individual
manufacturing facility as well as the broader Plan to comprise one Plan
for each manufacturer. Based on FDA's data on the number of
manufacturers that would be covered by the guidance, we estimate that
approximately 70 manufacturers will develop a Plan as recommended by
the guidance (i.e., one Plan per manufacturer to include all
manufacturing facilities, sites, and drug products), and that each Plan
will take approximately 500 hours to develop, maintain, and update.
The guidance also encourages manufacturers to include a procedure
in their Plan for notifying the Center for Drug Evaluation and Research
(CDER) when the Plan is activated and when returning to normal
operations. The guidance recommends that these notifications occur
within 1 day of a Plan's activation and within 1 day of a Plan's
deactivation. The guidance specifies the information that should be
included in these notifications, such as which drug products will be
manufactured under altered procedures, which products will have
manufacturing temporarily delayed, and any anticipated or potential
drug shortages. We expect that approximately two notifications (for
purposes of this analysis, we consider an activation and a deactivation
notification to equal one notification) will be sent to CDER by
approximately two manufacturers each year, and that each notification
will take approximately 16 hours to prepare and submit.
The guidance also refers to previously approved collections of
information found in FDA regulations. Under the guidance, if a
manufacturer obtains information after releasing an MNP under its Plan
leading to suspicion that the product might be defective, CDER should
be contacted immediately at drugshortages@fda.hhs.gov in adherence to
existing recall reporting regulations (21 CFR 7.40) (OMB control number
0910-0249), or defect reporting requirements for drug application
products (21 CFR 314.81(b)(1)) and therapeutic biological products
regulated by CDER (21 CFR 600.14) (OMB control numbers 0910-0001 and
0910-0458, respectively).
In addition, the following collections of information found in FDA
current good manufacturing practice (CGMP) regulations in part 211 (21
CFR part 211) are approved under OMB control number 0190-0139. The
guidance encourages manufacturers to maintain records, in accordance
with the CGMP requirements (see, e.g., Sec. 211.180) that support
decisions to carry out changes to approved procedures for manufacturing
and release of products under the Plan. The guidance states that a Plan
should be developed, written, reviewed, and approved within the site's
change control quality system in accordance with the requirements in
Sec. Sec. 211.100(a) and 211.160(a); execution of the Plan should be
documented in accordance with the requirements described in Sec.
211.100(b); and standard operating procedures should be reviewed and
revised or supplementary procedures developed and approved to enable
execution of the Plan.
In the Federal Register of November 3, 2016 (81 FR 76618), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.
We estimate the burden of this information collection as follows:
[[Page 13823]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Absenteeism guidance Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notify FDA of Plan Activation and Deactivation...... 2 1 2 16 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden per
Absenteeism guidance recordkeepers per recordkeeper records recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop Initial Plan................................ 70 1 70 500 35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05100 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P