Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs, 81332-81335 [2015-32685]
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Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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
the information collection contained in
FDA’s regulations on current good
manufacturing practice (CGMP) for
positron emission tomography (PET)
drugs.
SUMMARY:
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Electroconvulsive Therapy (ECT)
Devices for Class II Intended Uses: Draft
Guidance for Industry, Clinicians, and
FDA Staff’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 1823 to identify the guidance
you are requesting.
Submit either electronic or
written comments on the collection of
information by February 29, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Food and Drug Administration
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’’).
[Docket No. FDA–2013–N–0242]
Written/Paper Submissions
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in 21 CFR part 807 subpart
E have been approved under OMB
control number 0910–0120; the
collection of information in 21 CFR 801
has been approved under OMB control
number 0910–0485; and the collection
of information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073.
Dated: December 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32591 Filed 12–28–15; 8:45 am]
BILLING CODE 4164–01–P
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Current Good
Manufacturing Practice for Positron
Emission Tomography Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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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
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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–
2013–N–0242 for ‘‘Agency Information
Collection Activities: Proposed
Collection; Comment Request; Current
Good Manufacturing Practice for
Positron Emission Tomography Drugs.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
E:\FR\FM\29DEN1.SGM
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Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
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.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Current Good Manufacturing Practice
for Positron Emission Tomography
Drugs (OMB Control Number 0910–
0667)—Extension
Positron emission tomography is a
medical imaging modality involving the
use of a unique type of
radiopharmaceutical drug product.
FDA’s CGMP regulations at 21 CFR part
212 are intended to ensure that PET
drug products meet the requirements of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) regarding safety,
identity, strength, quality, and purity.
The CGMP requirements for PET drugs
are issued under the provisions of the
Food and Drug Administration
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Modernization Act of 1997 (the
Modernization Act). These CGMP
requirements are designed to take into
account the unique characteristics of
PET drugs, including their short halflives and the fact that most PET drugs
are produced at locations that are very
close to the patients to whom the drugs
are administered.
The CGMP regulations are intended to
ensure that approved PET drugs meet
the requirements of the FD&C Act as to
safety, identity, strength, quality, and
purity. The regulations address the
following matters: Personnel and
resources; quality assurance; facilities
and equipment; control of components,
in-process materials, and finished
products; production and process
controls; laboratory controls; acceptance
criteria; labeling and packaging controls;
distribution controls; complaint
handling; and recordkeeping.
The CGMP regulations establish
several recordkeeping requirements and
a third-party disclosure requirement for
the production of PET drugs. In making
our estimates of the time spent in
complying with these information
collection requirements, we relied on
communications we have had with PET
producers, visits by our staff to PET
facilities, and our familiarity with both
PET and general pharmaceutical
manufacturing practices. The estimated
annual recordkeeping and third-party
disclosure burden is based on there
being approximately 129 PET drug
production facilities.
As explained in this document, Table
1 provides an estimate of the annual
recordkeeping burdens and Table 2
provides an estimate of the annual
third-party disclosure burdens
associated with this collection.
I. Investigational and Research PET
Drugs
Section 212.5(b)(2) provides that for
investigational PET drugs produced
under an investigational new drug (IND)
and research PET drugs produced with
approval of a Radioactive Drug Research
Committee (RDRC), the requirement
under the FD&C Act to follow current
good manufacturing practice is met by
complying with the regulations in part
212 or with USP 32 Chapter 823. We
believe that PET production facilities
producing drugs under INDs and RDRCs
are currently substantially complying
with the recordkeeping requirements of
USP 32 Chapter 823 (see section 121(b)
of the Modernization Act), and
accordingly, we do not estimate any
recordkeeping burden for this provision.
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81333
II. Batch Production and Control
Records
Sections 212.20(c) through (e),
212.50(a) through (c), and 212.80(c) set
forth requirements for batch and
production records as well as written
control records. We estimate that it
would take approximately 20 hours
annually for each PET production
facility to prepare and maintain written
production and control procedures and
to create and maintain master batch
records for each PET drug produced. We
also estimate that there will be a total of
approximately 221 PET drugs produced,
with a total recordkeeping burden of
approximately 4,420 hours. We estimate
that it would take a PET production
facility an average of 30 minutes to
complete a batch record for each of
approximately 501 batches. Our
estimated burden for completing batch
records is approximately 32,320 hours.
III. Equipment and Facilities Records
Sections 212.20(c), 212.30(b),
212.50(d), and 212.60(f) contain
requirements for records dealing with
equipment and physical facilities. We
estimate that it would take
approximately 1 hour to establish and
maintain these records for each piece of
equipment in each PET production
facility. We estimate that the total
burden for establishing procedures for
these records would be approximately
1,939 hours. We estimate that recording
maintenance and cleaning information
would take approximately 5 minutes a
day for each piece of equipment, with
a total recordkeeping burden of
approximately 40,238 hours.
IV. Records of Components, Containers,
and Closures
Sections 212.20(c) and 212.40(a), (b),
and (e) contain requirements on records
regarding receiving and testing of
components, containers, and closures.
We estimate that the annual burden for
establishing these records would be
approximately 259 hours. We estimate
that each facility would receive
approximately 36 shipments annually
and would spend approximately 10
minutes per shipment entering records.
The annual burden for maintaining
these records would be approximately
773 hours.
V. Process Verification
Section 212.50(f)(2) requires that any
process verification activities and
results be recorded. Because process
verification is only required when
results of the production of an entire
batch are not fully verified through
finished-product testing, we believe that
process verification will be a very rare
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Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
occurrence, and we do not estimate any
recordkeeping burden for documenting
process verification.
VI. Laboratory Testing Records
Sections 212.20(c), 212.60(a), (b), and
(g), 212.61(a) through (b), and 212.70(a),
(b), and (d) set out requirements for
documenting laboratory testing and
specifications referred to in laboratory
testing, including final release testing
and stability testing. Each PET drug
production facility will need to
establish procedures and create forms
for the different tests for each product
they produce. We estimate that it will
take each facility an average of 1 hour
to establish procedures and create forms
for one test. The estimated annual
burden for establishing procedures and
creating forms for these records is
approximately 3,232 hours, and the
annual burden for recording laboratory
test results is approximately 10,730
hours.
VII. Sterility Test Failure Notices
Section 212.70(e) requires PET drug
producers to notify all receiving
facilities if a batch fails sterility tests.
We believe that sterility test failures
might occur in only 0.05 percent of the
batches of PET drugs produced each
year. Therefore, we have estimated in
Table 2 that each PET drug producer
will need to provide approximately 0.25
sterility test failure notice per year to
receiving facilities. The notice would be
provided using email or facsimile
transmission and should take no more
than 1 hour.
VIII. Conditional Final Releases
Section 212.70(f) requires PET drug
producers to document any conditional
final releases of a product. We believe
that conditional final releases will be
fairly uncommon, but for purposes of
the PRA, we estimated that each PET
production facility would have one
conditional final release a year and
would spend approximately 1 hour
documenting the release and notifying
receiving facilities. The estimate of one
conditional final release per year per
facility is an appropriate average
number because many facilities may
have no conditional final releases while
others might have only a few.
IX. Out-of-Specification Investigations
Sections 212.20(c) and 212.71(a) and
(b) require PET drug producers to
establish procedures for investigating
products that do not conform to
specifications and conduct these
investigations as needed. We estimate
that it will take approximately 1 hour
annually to record and update these
procedures for each PET production
facility. We also estimate, for purposes
of the PRA, that 36 out-of-specification
investigations would be conducted at
each facility each year and that it would
take approximately 1 hour to document
the investigation, which results in an
annual burden of 4,654 hours.
X. Reprocessing Procedures
Sections 212.20(c) and 212.71(d)
require PET drug producers to establish
and document procedures for
reprocessing PET drugs. We estimate
that it will take approximately 1 hour a
year to document these procedures for
each PET production facility. We do not
estimate a separate burden for recording
the actual reprocessing, both because we
believe it would be an uncommon event
and because the recordkeeping burden
has been included in our estimate for
batch production and control records.
XI. Distribution Records
Sections 212.20(c) and 212.90(a)
require that written procedures
regarding distribution of PET drug
products be established and maintained.
We estimate that it will take
approximately 1 hour annually to
establish and maintain records of these
procedures for each PET production
facility. Section 212.90(b) requires that
distribution records be maintained. We
estimate that it will take approximately
15 minutes to create an actual
distribution record for each batch of
PET drug products, with a total burden
of approximately 16,160 hours for all
PET producers.
XII. Complaints
Sections 212.20(c) and 212.100
require that PET drug producers
establish written procedures for dealing
with complaints, as well as document
how each complaint is handled. We
estimate that establishing and
maintaining written procedures for
complaints will take approximately 1
hour annually for each PET production
facility and that each facility will
receive approximately one complaint a
year and will spend approximately 30
minutes recording how the complaint
was dealt with.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of
recordkeepers
asabaliauskas on DSK5VPTVN1PROD with NOTICES
21 CFR Section
Batch Production and Control Records
212.20(c), 212.20(e); 212.50(a), 212.50(b).
Batch Production and Control Records
212.20(d) and (e); 212.50(c); 212.80(c).
Equipment and Facilities Records 212.20(c);
212.30(b); 212.50(d), 212.60(f).
Equipment and Facilities Records 212.30(b),
212.50(d); 212.60(f).
Records of Components, Containers, and
Closures 212.20(c); 212.40(a), 212.40(b).
Records of Components, Containers, and
Closures 212.40(e).
Laboratory Testing Records 212.20(c);
212.60(a), 212.60(b), 212.61(a); 212.70(a),
212.70(b), 212.70(d).
Laboratory Testing Records 212.60(g);
212.61(b); 212.70(d)(2), 212.70(d)(3).
Conditional Final Releases 212.70(f) .............
Out-of-Specification Investigations 212.20(c);
212.71(a).
Reprocessing Procedures 212.71(b) .............
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No. of records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
129
1.71
221
20 ................
4,420
129
501
64,640
32,320
129
15
1,939
0.5 (30
mins.)
1 ..................
129
3,758
484,800
40,238
129
2
259
0.083 (5
mins.)
1 ..................
129
36
4,654
773
129
25
3,232
0.166 (10
mins.)
1 ..................
129
501
64,640
129
129
1
36
129
1
Frm 00063
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1,939
259
3,232
10,730
129
4,654
0.166 (10
min.)
1 ..................
1 ..................
129
1 ..................
129
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4,654
Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
81335
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
No. of
recordkeepers
21 CFR Section
No. of records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Reprocessing
Procedures
212.20(c);
212.71(d).
Reprocessing
Procedures
212.20(c);
212.90(a).
Distribution Records 212.90(b) ......................
129
1
129
1 ..................
129
129
1
129
1 ..................
129
129
501
64,640
16,160
Complaints 212.20(c); 212.100(a) ..................
Complaints 212.100(b), 212.100(c) ................
129
129
1
1
129
129
0.25 (15
mins.)
1 ..................
0.5 (30
mins.)
Total ........................................................
..............................
..............................
..............................
.....................
115,435
1 There
129
65
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
No. of
respondents
Annual frequency
of disclosure
Total annual disclosures
Hours per disclosure
Total hours
129
21 CFR section
0.25
32
1
32
Sterility Test Failure Notices 212.70(e)
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
Dated: December 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Although you can comment on
any guidance at any time, submit either
electronic or written comments by
February 29, 2016.
DATES:
[FR Doc. 2015–32685 Filed 12–28–15; 8:45 am]
BILLING CODE 4164–01–P
ADDRESSES:
You may submit comments
as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2012–N–1021]
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2016
Proposed Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the Web site location where
the Agency will post two lists of
guidance documents that the Center for
Devices and Radiological Health (CDRH
or the Center) intends to publish in
Fiscal Year (FY) 2016. In addition, FDA
has established a docket, where
interested persons may comment on the
priority of topics for guidance, provide
comments and/or propose draft
language for those topics, suggest topics
for new or different guidance
documents, comment on the
applicability of guidance documents
that have issued previously, and
provide early input to support
guidances that will be developed.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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19:17 Dec 28, 2015
Jkt 238001
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 00064
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–
2015–N–1021 for ‘‘Medical Device User
Fee and Modernization Act; Notice to
Public of Web site Location of Fiscal
Year 2016 Proposed Guidance
Development.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
E:\FR\FM\29DEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81332-81335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32685]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0242]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Current Good Manufacturing Practice for Positron
Emission Tomography Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 the information collection
contained in FDA's regulations on current good manufacturing practice
(CGMP) for positron emission tomography (PET) drugs.
DATES: Submit either electronic or written comments on the collection
of information by February 29, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, 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-2013-N-0242 for ``Agency Information Collection Activities:
Proposed Collection; Comment Request; Current Good Manufacturing
Practice for Positron Emission Tomography Drugs.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 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.
Current Good Manufacturing Practice for Positron Emission Tomography
Drugs (OMB Control Number 0910-0667)--Extension
Positron emission tomography is a medical imaging modality
involving the use of a unique type of radiopharmaceutical drug product.
FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that
PET drug products meet the requirements of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) regarding safety, identity, strength,
quality, and purity. The CGMP requirements for PET drugs are issued
under the provisions of the Food and Drug Administration Modernization
Act of 1997 (the Modernization Act). These CGMP requirements are
designed to take into account the unique characteristics of PET drugs,
including their short half-lives and the fact that most PET drugs are
produced at locations that are very close to the patients to whom the
drugs are administered.
The CGMP regulations are intended to ensure that approved PET drugs
meet the requirements of the FD&C Act as to safety, identity, strength,
quality, and purity. The regulations address the following matters:
Personnel and resources; quality assurance; facilities and equipment;
control of components, in-process materials, and finished products;
production and process controls; laboratory controls; acceptance
criteria; labeling and packaging controls; distribution controls;
complaint handling; and recordkeeping.
The CGMP regulations establish several recordkeeping requirements
and a third-party disclosure requirement for the production of PET
drugs. In making our estimates of the time spent in complying with
these information collection requirements, we relied on communications
we have had with PET producers, visits by our staff to PET facilities,
and our familiarity with both PET and general pharmaceutical
manufacturing practices. The estimated annual recordkeeping and third-
party disclosure burden is based on there being approximately 129 PET
drug production facilities.
As explained in this document, Table 1 provides an estimate of the
annual recordkeeping burdens and Table 2 provides an estimate of the
annual third-party disclosure burdens associated with this collection.
I. Investigational and Research PET Drugs
Section 212.5(b)(2) provides that for investigational PET drugs
produced under an investigational new drug (IND) and research PET drugs
produced with approval of a Radioactive Drug Research Committee (RDRC),
the requirement under the FD&C Act to follow current good manufacturing
practice is met by complying with the regulations in part 212 or with
USP 32 Chapter 823. We believe that PET production facilities producing
drugs under INDs and RDRCs are currently substantially complying with
the recordkeeping requirements of USP 32 Chapter 823 (see section
121(b) of the Modernization Act), and accordingly, we do not estimate
any recordkeeping burden for this provision.
II. Batch Production and Control Records
Sections 212.20(c) through (e), 212.50(a) through (c), and
212.80(c) set forth requirements for batch and production records as
well as written control records. We estimate that it would take
approximately 20 hours annually for each PET production facility to
prepare and maintain written production and control procedures and to
create and maintain master batch records for each PET drug produced. We
also estimate that there will be a total of approximately 221 PET drugs
produced, with a total recordkeeping burden of approximately 4,420
hours. We estimate that it would take a PET production facility an
average of 30 minutes to complete a batch record for each of
approximately 501 batches. Our estimated burden for completing batch
records is approximately 32,320 hours.
III. Equipment and Facilities Records
Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) contain
requirements for records dealing with equipment and physical
facilities. We estimate that it would take approximately 1 hour to
establish and maintain these records for each piece of equipment in
each PET production facility. We estimate that the total burden for
establishing procedures for these records would be approximately 1,939
hours. We estimate that recording maintenance and cleaning information
would take approximately 5 minutes a day for each piece of equipment,
with a total recordkeeping burden of approximately 40,238 hours.
IV. Records of Components, Containers, and Closures
Sections 212.20(c) and 212.40(a), (b), and (e) contain requirements
on records regarding receiving and testing of components, containers,
and closures. We estimate that the annual burden for establishing these
records would be approximately 259 hours. We estimate that each
facility would receive approximately 36 shipments annually and would
spend approximately 10 minutes per shipment entering records. The
annual burden for maintaining these records would be approximately 773
hours.
V. Process Verification
Section 212.50(f)(2) requires that any process verification
activities and results be recorded. Because process verification is
only required when results of the production of an entire batch are not
fully verified through finished-product testing, we believe that
process verification will be a very rare
[[Page 81334]]
occurrence, and we do not estimate any recordkeeping burden for
documenting process verification.
VI. Laboratory Testing Records
Sections 212.20(c), 212.60(a), (b), and (g), 212.61(a) through (b),
and 212.70(a), (b), and (d) set out requirements for documenting
laboratory testing and specifications referred to in laboratory
testing, including final release testing and stability testing. Each
PET drug production facility will need to establish procedures and
create forms for the different tests for each product they produce. We
estimate that it will take each facility an average of 1 hour to
establish procedures and create forms for one test. The estimated
annual burden for establishing procedures and creating forms for these
records is approximately 3,232 hours, and the annual burden for
recording laboratory test results is approximately 10,730 hours.
VII. Sterility Test Failure Notices
Section 212.70(e) requires PET drug producers to notify all
receiving facilities if a batch fails sterility tests. We believe that
sterility test failures might occur in only 0.05 percent of the batches
of PET drugs produced each year. Therefore, we have estimated in Table
2 that each PET drug producer will need to provide approximately 0.25
sterility test failure notice per year to receiving facilities. The
notice would be provided using email or facsimile transmission and
should take no more than 1 hour.
VIII. Conditional Final Releases
Section 212.70(f) requires PET drug producers to document any
conditional final releases of a product. We believe that conditional
final releases will be fairly uncommon, but for purposes of the PRA, we
estimated that each PET production facility would have one conditional
final release a year and would spend approximately 1 hour documenting
the release and notifying receiving facilities. The estimate of one
conditional final release per year per facility is an appropriate
average number because many facilities may have no conditional final
releases while others might have only a few.
IX. Out-of-Specification Investigations
Sections 212.20(c) and 212.71(a) and (b) require PET drug producers
to establish procedures for investigating products that do not conform
to specifications and conduct these investigations as needed. We
estimate that it will take approximately 1 hour annually to record and
update these procedures for each PET production facility. We also
estimate, for purposes of the PRA, that 36 out-of-specification
investigations would be conducted at each facility each year and that
it would take approximately 1 hour to document the investigation, which
results in an annual burden of 4,654 hours.
X. Reprocessing Procedures
Sections 212.20(c) and 212.71(d) require PET drug producers to
establish and document procedures for reprocessing PET drugs. We
estimate that it will take approximately 1 hour a year to document
these procedures for each PET production facility. We do not estimate a
separate burden for recording the actual reprocessing, both because we
believe it would be an uncommon event and because the recordkeeping
burden has been included in our estimate for batch production and
control records.
XI. Distribution Records
Sections 212.20(c) and 212.90(a) require that written procedures
regarding distribution of PET drug products be established and
maintained. We estimate that it will take approximately 1 hour annually
to establish and maintain records of these procedures for each PET
production facility. Section 212.90(b) requires that distribution
records be maintained. We estimate that it will take approximately 15
minutes to create an actual distribution record for each batch of PET
drug products, with a total burden of approximately 16,160 hours for
all PET producers.
XII. Complaints
Sections 212.20(c) and 212.100 require that PET drug producers
establish written procedures for dealing with complaints, as well as
document how each complaint is handled. We estimate that establishing
and maintaining written procedures for complaints will take
approximately 1 hour annually for each PET production facility and that
each facility will receive approximately one complaint a year and will
spend approximately 30 minutes recording how the complaint was dealt
with.
Table 1--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of records Total annual Average burden per
21 CFR Section recordkeepers per recordkeeper records recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Batch Production and Control Records 129 1.71 221 20............................. 4,420
212.20(c), 212.20(e); 212.50(a), 212.50(b).
Batch Production and Control Records 129 501 64,640 0.5 (30 mins.) 32,320
212.20(d) and (e); 212.50(c); 212.80(c).
Equipment and Facilities Records 212.20(c); 129 15 1,939 1.............................. 1,939
212.30(b); 212.50(d), 212.60(f).
Equipment and Facilities Records 212.30(b), 129 3,758 484,800 0.083 (5 mins.) 40,238
212.50(d); 212.60(f).
Records of Components, Containers, and 129 2 259 1.............................. 259
Closures 212.20(c); 212.40(a), 212.40(b).
Records of Components, Containers, and 129 36 4,654 0.166 (10 mins.) 773
Closures 212.40(e).
Laboratory Testing Records 212.20(c); 129 25 3,232 1.............................. 3,232
212.60(a), 212.60(b), 212.61(a);
212.70(a), 212.70(b), 212.70(d).
Laboratory Testing Records 212.60(g); 129 501 64,640 0.166 (10 min.) 10,730
212.61(b); 212.70(d)(2), 212.70(d)(3).
Conditional Final Releases 212.70(f)....... 129 1 129 1.............................. 129
Out-of-Specification Investigations 129 36 4,654 1.............................. 4,654
212.20(c); 212.71(a).
Reprocessing Procedures 212.71(b).......... 129 1 129 1.............................. 129
[[Page 81335]]
Reprocessing Procedures 212.20(c); 129 1 129 1.............................. 129
212.71(d).
Reprocessing Procedures 212.20(c); 129 1 129 1.............................. 129
212.90(a).
Distribution Records 212.90(b)............. 129 501 64,640 0.25 (15 mins.) 16,160
Complaints 212.20(c); 212.100(a)........... 129 1 129 1.............................. 129
Complaints 212.100(b), 212.100(c).......... 129 1 129 0.5 (30 mins.) 65
------------------------------------------------------------------------------------------------------------
Total.................................. ................. ................. ................. ............................... 115,435
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual frequency Total annual Hours per
21 CFR section respondents of disclosure disclosures disclosure Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sterility Test Failure Notices 212.70(e)............ 129 0.25 32 1 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
Dated: December 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32685 Filed 12-28-15; 8:45 am]
BILLING CODE 4164-01-P
