Agency Information Collection Activities; Proposed Collection; Comment Request; Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products, 16108-16110 [2018-07684]
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16108
Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
number 0910–0485; the collections of
information in 21 CFR part 814,
subparts A through E, regarding
premarket approval, have been
approved under OMB control number
0910–0231; the collections of
information in 21 CFR part 820,
regarding the quality system regulation,
have been approved under OMB control
number 0910–0073; and the collections
of information in the guidance
document ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
have been approved under OMB control
number 0910–0756.
Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07687 Filed 4–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1111]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Permanent
Discontinuation or Interruption in
Manufacturing of Certain Drug and
Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on ‘‘Permanent
Discontinuation or Interruption in
Manufacturing of Certain Drug and
Biological Products.’’
DATES: Submit either electronic or
written comments on the collection of
information by June 12, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 12, 2018.
The https://www.regulations.gov
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SUMMARY:
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electronic filing system will accept
comments until midnight Eastern Time
at the end of June 12, 2018. 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.
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–N–1111 for ‘‘Permanent
Discontinuation or Interruption in
Manufacturing of Certain Drug and
Biological Products.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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
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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
‘‘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
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Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
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,
including each proposed extension of an
existing 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.
Permanent Discontinuation or
Interruption in Manufacturing of
Certain Drug and Biological Products—
21 CFR 310.306, 314.81(b)(3)(iii), and
600.82
OMB Control Number 0910–0759—
Extension
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Sections 310.306, 314.81(b)(3)(iii),
and 600.82 (21 CFR 310.306,
314.81(b)(3)(iii), and 600.82) were
modified to implement sections 506C
and 506E of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356c and 356e)
as amended by the Food and Drug
Administration Safety and Innovation
Act. Under these sections, applicants
with an approved new drug application
(NDA) or abbreviated new drug
application (ANDA) for a covered drug
product, manufacturers of a covered
drug product marketed without an
approved application, and applicants
with an approved biologics license
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Jkt 244001
application (BLA) for a covered
biological product (including certain
applications of blood or blood
components) must notify FDA in
writing of a permanent discontinuance
of the manufacture of the drug or
biological product, or an interruption in
manufacturing of the drug or biological
product, that is likely to lead to a
meaningful disruption in the applicant’s
supply (or a significant disruption for
blood or blood components) of that
product. The notification is required if
the drug or biological product is life
supporting, life sustaining, or intended
for use in the prevention or treatment of
a debilitating disease or condition,
including use in emergency medical
care or during surgery, and if the drug
or biological product is not a
radiopharmaceutical drug product.
The regulations also require that the
notification include the following
information: (1) The name of the drug or
biological product subject to the
notification, including the National
Drug Code Directory (NDC) (or, for a
biological product that does not have an
NDC, an alternative standard for
identification and labeling that has been
recognized as acceptable by the Center
Director); (2) the name of each applicant
of the drug or biological product; (3)
whether the notification relates to a
permanent discontinuance of the drug
or biological product or an interruption
in manufacturing of the product; (4) a
description of the reason for the
permanent discontinuance or
interruption in manufacturing; and (5)
the estimated duration of the
interruption in manufacturing. The
notification must be submitted to FDA
electronically at least 6 months prior to
the date of the permanent
discontinuance or interruption in
manufacturing. If 6 months’ advance
notice is not possible because the
permanent discontinuance or
interruption in manufacturing was
unanticipated 6 months in advance, the
applicant must notify FDA as soon as
practicable, but in no case later than 5
business days after the permanent
discontinuance or interruption in
manufacturing occurs.
If an applicant fails to submit the
required notification, FDA will issue a
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16109
letter informing the applicant or
manufacturer of its noncompliance. The
applicant must submit to FDA, not later
than 30 calendar days after FDA issues
the letter, a written response setting
forth the basis for noncompliance and
providing the required notification.
Description of Respondents:
Applicants of prescription drugs and
biological products subject to an
approved NDA, ANDA, or BLA, and
manufacturers of prescription drug
products marketed without an approved
ANDA or NDA, if the product is life
supporting, life sustaining, or intended
for use in the prevention or treatment of
a debilitating disease or condition,
including use in emergency medical
care or during surgery, or is not a
radiopharmaceutical product. If the BLA
applicant is a manufacturer of blood or
blood components, it is only subject to
these regulations if it manufactures a
significant percentage of the nation’s
blood supply.
Burden Estimates: Based on the
number of drug and biological product
shortage related notifications we have
seen in the past 12 months, we estimate
that annually a total of approximately
75 respondents (‘‘No. of Respondents’’
in table 1) will notify us of a permanent
discontinuance of the manufacture of a
drug or biological product or an
interruption in manufacturing of a drug
or biological product that is likely to
lead to a meaningful disruption in the
respondent’s supply of that product. We
estimate that these respondents will
submit annually a total of
approximately 352.5 notifications as
required under §§ 310.306,
314.81(b)(3)(iii), and 600.82. We
estimate 4.7 notifications per
respondent, because a respondent may
experience multiple discontinuances or
interruptions in manufacturing in a year
that require notification (‘‘No. of
Responses per Respondent’’ in table 1).
We also estimate that preparing and
submitting these notifications to FDA
will take approximately 2 hours per
respondent (‘‘Average Burden per
Response’’ in table 1).
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
TABLE 1—ESTIMATED REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notifications required under §§ 310.306 (unapproved
drugs), 314.81(b)(3)(iii) (products approved under an
NDA or ANDA), and 600.82 (products approved under a
BLA) ..................................................................................
75
4.7
352.5
2
705
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated burden for this
information collection has changed
since the previous OMB approval. The
current burden is based on the number
of actual new notifications received
including notifications that were
counted previously under the OMB
approval for the interim final rule
entitled ‘‘Permanent Discontinuance or
Interruption in Manufacturing of Certain
Drug or Biological Products’’ (80 FR
38915, July 8, 2015) (OMB control
number 0910–0699).
Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07684 Filed 4–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1233]
Use of Public Human Genetic Variant
Databases To Support Clinical Validity
for Genetic and Genomic-Based In
Vitro Diagnostics; Guidance for
Stakeholders and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the final
guidance entitled ‘‘Use of Public Human
Genetic Variant Databases to Support
Clinical Validity for Genetic and
Genomic-Based In Vitro Diagnostics;
Guidance for Stakeholders and Food
and Drug Administration Staff.’’ This
guidance document describes how
publicly accessible databases of human
genetic variants can serve as sources of
valid scientific evidence to support the
clinical validity of genotype-phenotype
relationships in FDA’s regulatory review
of genetic and genomic-based tests. This
guidance further outlines the process by
which administrators of genetic variant
databases could voluntarily apply to
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SUMMARY:
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FDA for recognition, and how FDA
would review such applications and
periodically reevaluate recognized
databases.
DATES: The announcement of the
guidance is published in the Federal
Register on April 13, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–1233 for ‘‘Use of Public Human
Genetic Variant Databases to Support
Clinical Validity for Genetic and
Genomic-Based In Vitro Diagnostics;
Guidance for Stakeholders and Food
and Drug Administration Staff.’’
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 office
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the 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.
E:\FR\FM\13APN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)]
[Notices]
[Pages 16108-16110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1111]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Permanent Discontinuation or Interruption in
Manufacturing of Certain Drug and Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Permanent Discontinuation or Interruption
in Manufacturing of Certain Drug and Biological Products.''
DATES: Submit either electronic or written comments on the collection
of information by June 12, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of June 12, 2018. 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.
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-N-1111 for ``Permanent Discontinuation or Interruption in
Manufacturing of Certain Drug and Biological Products.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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 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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: 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.
``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
[[Page 16109]]
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, including each proposed extension of an existing
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.
Permanent Discontinuation or Interruption in Manufacturing of Certain
Drug and Biological Products--21 CFR 310.306, 314.81(b)(3)(iii), and
600.82
OMB Control Number 0910-0759--Extension
Sections 310.306, 314.81(b)(3)(iii), and 600.82 (21 CFR 310.306,
314.81(b)(3)(iii), and 600.82) were modified to implement sections 506C
and 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c
and 356e) as amended by the Food and Drug Administration Safety and
Innovation Act. Under these sections, applicants with an approved new
drug application (NDA) or abbreviated new drug application (ANDA) for a
covered drug product, manufacturers of a covered drug product marketed
without an approved application, and applicants with an approved
biologics license application (BLA) for a covered biological product
(including certain applications of blood or blood components) must
notify FDA in writing of a permanent discontinuance of the manufacture
of the drug or biological product, or an interruption in manufacturing
of the drug or biological product, that is likely to lead to a
meaningful disruption in the applicant's supply (or a significant
disruption for blood or blood components) of that product. The
notification is required if the drug or biological product is life
supporting, life sustaining, or intended for use in the prevention or
treatment of a debilitating disease or condition, including use in
emergency medical care or during surgery, and if the drug or biological
product is not a radiopharmaceutical drug product.
The regulations also require that the notification include the
following information: (1) The name of the drug or biological product
subject to the notification, including the National Drug Code Directory
(NDC) (or, for a biological product that does not have an NDC, an
alternative standard for identification and labeling that has been
recognized as acceptable by the Center Director); (2) the name of each
applicant of the drug or biological product; (3) whether the
notification relates to a permanent discontinuance of the drug or
biological product or an interruption in manufacturing of the product;
(4) a description of the reason for the permanent discontinuance or
interruption in manufacturing; and (5) the estimated duration of the
interruption in manufacturing. The notification must be submitted to
FDA electronically at least 6 months prior to the date of the permanent
discontinuance or interruption in manufacturing. If 6 months' advance
notice is not possible because the permanent discontinuance or
interruption in manufacturing was unanticipated 6 months in advance,
the applicant must notify FDA as soon as practicable, but in no case
later than 5 business days after the permanent discontinuance or
interruption in manufacturing occurs.
If an applicant fails to submit the required notification, FDA will
issue a letter informing the applicant or manufacturer of its
noncompliance. The applicant must submit to FDA, not later than 30
calendar days after FDA issues the letter, a written response setting
forth the basis for noncompliance and providing the required
notification.
Description of Respondents: Applicants of prescription drugs and
biological products subject to an approved NDA, ANDA, or BLA, and
manufacturers of prescription drug products marketed without an
approved ANDA or NDA, if the product is life supporting, life
sustaining, or intended for use in the prevention or treatment of a
debilitating disease or condition, including use in emergency medical
care or during surgery, or is not a radiopharmaceutical product. If the
BLA applicant is a manufacturer of blood or blood components, it is
only subject to these regulations if it manufactures a significant
percentage of the nation's blood supply.
Burden Estimates: Based on the number of drug and biological
product shortage related notifications we have seen in the past 12
months, we estimate that annually a total of approximately 75
respondents (``No. of Respondents'' in table 1) will notify us of a
permanent discontinuance of the manufacture of a drug or biological
product or an interruption in manufacturing of a drug or biological
product that is likely to lead to a meaningful disruption in the
respondent's supply of that product. We estimate that these respondents
will submit annually a total of approximately 352.5 notifications as
required under Sec. Sec. 310.306, 314.81(b)(3)(iii), and 600.82. We
estimate 4.7 notifications per respondent, because a respondent may
experience multiple discontinuances or interruptions in manufacturing
in a year that require notification (``No. of Responses per
Respondent'' in table 1). We also estimate that preparing and
submitting these notifications to FDA will take approximately 2 hours
per respondent (``Average Burden per Response'' in table 1).
FDA estimates the burden of this collection of information as
follows:
[[Page 16110]]
Table 1--Estimated Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Notifications required under Sec. Sec. 310.306 (unapproved 75 4.7 352.5 2 705
drugs), 314.81(b)(3)(iii) (products approved under an NDA or
ANDA), and 600.82 (products approved under a BLA).................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated burden for this information collection has changed
since the previous OMB approval. The current burden is based on the
number of actual new notifications received including notifications
that were counted previously under the OMB approval for the interim
final rule entitled ``Permanent Discontinuance or Interruption in
Manufacturing of Certain Drug or Biological Products'' (80 FR 38915,
July 8, 2015) (OMB control number 0910-0699).
Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07684 Filed 4-12-18; 8:45 am]
BILLING CODE 4164-01-P
