Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities, 32882-32883 [2018-15095]
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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
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FOR FURTHER INFORMATION CONTACT:
Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Guidance for Industry on Compounding
and Repackaging of
Radiopharmaceuticals by StateLicensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities
[FR Doc. 2018–15096 Filed 7–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4318]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Compounding and
Repackaging of Radiopharmaceuticals
by State-Licensed Nuclear Pharmacies,
Federal Facilities, and Certain Other
Entities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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.
DATES: Fax written comments on the
collection of information by August 15,
2018.
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–NEW and
title ‘‘Guidance for Industry on
Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies, Federal Facilities,
and Certain Other Entities.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number—NEW
This information collection supports
the Agency guidance document entitled
‘‘Guidance for Industry on
Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies, Federal Facilities,
and Certain Other Entities.’’
Under current law,
radiopharmaceuticals that are
compounded by entities that are not
registered with FDA as outsourcing
facilities, and radiopharmaceuticals that
are repackaged, are subject to all
applicable provisions of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) related to drug production. Because
Congress explicitly excluded
radiopharmaceuticals from section 503A
of the FD&C Act (21 U.S.C. 353a) (see
section 503A(d)(2)), compounded
radiopharmaceuticals are not eligible for
the exemptions under section 503A
from section 505 of the FD&C Act (21
U.S.C. 355) (concerning new drug
approval requirements), section
502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) (concerning labeling with
adequate directions for use), and section
501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice requirements).
In addition, the FD&C Act does not
provide an exemption for repackaged
radiopharmaceuticals.
FDA developed this guidance
document to describe the conditions
under which the Agency generally does
not intend to take action for violations
of sections 505, 502(f)(1), and
501(a)(2)(B) of the FD&C Act when a
State-licensed nuclear pharmacy,
Federal facility, or other facility that is
not an outsourcing facility and that
holds a radioactive materials license for
medical use issued by the Nuclear
Regulatory Commission or by an
Agreement State compounds or
repackages radiopharmaceuticals for
human use.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
One of the guidance document’s
conditions is that the compounded
radiopharmaceutical is not essentially a
copy of an approved
radiopharmaceutical. If a compounder
intends to rely on a determination from
a prescriber that there is a change
between the compounded
radiopharmaceutical and the
comparable approved
radiopharmaceutical that produces a
clinical difference for an identified
individual patient, either the
prescribing practitioner or the
compounder documents the
determination on the prescription or
order in writing. This documentation
reflects a conversation with the
prescribing practitioner, and the
compounder maintains records of the
prescription or order documenting this
determination.
In the Federal Register of December
29, 2016 (81 FR 96011), FDA published
a notice of availability for the draft
guidance, including a 60-day notice
soliciting public comment on the
information collection
recommendations. Several comments
were received and are discussed below;
however, none of the comments
suggested we revise the burden estimate
from our 60-day notice.
(Comment 1) One commenter said
documentation of a minor deviation
from an approved radiopharmaceutical
should remain at the facility that
performed the minor deviation.
(Response 1) The documentation
condition (i.e., documentation of a
prescriber’s determination that there is
a change that produces a clinical
difference between the compounded
radiopharmaceutical and the
comparable FDA-approved
radiopharmaceutical for an identified
individual patient) does not apply to
compounding that consists only of
minor deviations as defined in the
guidance document (i.e., a change from
the approved labeling in radioactivity,
volume, or the step-by-step procedures
made when compounding the
radiopharmaceutical from an FDAapproved drug product in a patientready dose). The documentation
condition applies to compounding a
radiopharmaceutical that involves
manipulation other than minor
deviations.
(Comment 2) One commenter
supports the requirement for notating
clinical differences, particularly for
documenting both the change to the
radiopharmaceutical and the reason that
the change is important for the patient.
(Response 2) FDA concurs with this
commenter’s views about the
importance of the documentation.
E:\FR\FM\16JYN1.SGM
16JYN1
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
FDA’s guidance document states that
the documentation condition would be
met if the prescription for the
compounded radiopharmaceutical
makes clear that the prescriber
identified the relevant change between
the approved radiopharmaceutical and
the compounded radiopharmaceutical
and the clinical difference that the
change produces for the patient.
(Comment 3) One commenter
recommended that the guidance
document require written
documentation when a commercially
manufactured radiopharmaceutical is
compounded for a patient because the
radiopharmaceutical is unavailable due
to a drug shortage.
(Response 3) The guidance document
explains that FDA does not consider a
compounded radiopharmaceutical to be
essentially a copy of a marketed FDAapproved radiopharmaceutical if the
FDA-approved radiopharmaceutical is
on FDA’s drug shortage list (see section
506E of the FD&C Act (21 U.S.C. 356e))
32883
at the time of compounding and
distribution. FDA maintains a database
for drug shortages. If the Agency
identifies a compounded
radiopharmaceutical that has the
characteristics of a drug that is
‘‘essentially a copy,’’ FDA intends to
review its database to determine
whether there was a shortage of the
approved radiopharmaceutical at the
time of compounding and distribution.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Type of reporting
Consultation between the compounder and prescriber and the notation on the prescription or
order documenting the prescriber’s determination
of clinical difference.
sradovich on DSK3GMQ082PROD with NOTICES
1 There
Number of
disclosures
per
respondent
10
Total annual
disclosures
25
250
Average burden
per disclosure
Total hours
0.05 (3 minutes) ........
12.5
are no capital costs or operating and maintenance costs associated with this collection of information.
The total estimated third-party
disclosure burden for the guidance
document is shown above.
We estimate that a total of
approximately 10 compounders
annually (‘‘No. of Respondents’’ in table
1, line 1) will consult a prescriber to
determine whether they decided that
the compounded radiopharmaceutical
has a change that produces a clinical
difference for an identified individual
patient as compared to the comparable
approved radiopharmaceutical. We
estimate that compounders will
document this determination on
approximately 250 prescriptions or
orders for compounded
radiopharmaceuticals (‘‘Total Annual
Disclosures’’ in table 1, line 1). We
estimate that the consultation between
the compounder and the prescriber and
noting this determination on each
prescription or order that does not
already document this determination
will take approximately 3 minutes per
prescription or order.
In the Federal Register of December
29, 2016 (81 FR 96011), FDA also
estimated the annual recordkeeping
burden for maintaining records of
prescriptions or orders documenting
certain information from prescribers.
While acquiring additional information
from the public about State pharmacy
practices since we published 81 FR
96011, FDA has determined that
because the time, effort, and financial
resources necessary to comply with this
collection of information would be
incurred by compounders in the normal
course of their activities, it is excluded
from the definition of ‘‘burden’’ under 5
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
CFR 1320.3(b)(2). FDA understands that
maintaining records of prescriptions for
compounded drug products is part of
the usual course of the practice of
compounding and selling drugs and is
required by States’ pharmacy laws and
other State laws governing record
keeping by healthcare professionals and
healthcare facilities.
Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15095 Filed 7–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by August 15,
2018.
DATES:
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 0910–0594. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2012–N–0115]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and FDA Staff—Class II
Special Controls Guidance Document:
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Separation Principle
AGENCY:
Food and Drug Administration,
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
E:\FR\FM\16JYN1.SGM
16JYN1
]]>Agencies
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32882-32883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15095]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-4318]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other
Entities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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.
DATES: Fax written comments on the collection of information by August
15, 2018.
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 [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Guidance for Industry on Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities.'' Also include the FDA docket
number found in brackets in the heading of this document.
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: 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 Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities
OMB Control Number--NEW
This information collection supports the Agency guidance document
entitled ``Guidance for Industry on Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities.''
Under current law, radiopharmaceuticals that are compounded by
entities that are not registered with FDA as outsourcing facilities,
and radiopharmaceuticals that are repackaged, are subject to all
applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) related to drug production. Because Congress explicitly excluded
radiopharmaceuticals from section 503A of the FD&C Act (21 U.S.C. 353a)
(see section 503A(d)(2)), compounded radiopharmaceuticals are not
eligible for the exemptions under section 503A from section 505 of the
FD&C Act (21 U.S.C. 355) (concerning new drug approval requirements),
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (concerning
labeling with adequate directions for use), and section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice requirements). In addition, the FD&C Act does
not provide an exemption for repackaged radiopharmaceuticals.
FDA developed this guidance document to describe the conditions
under which the Agency generally does not intend to take action for
violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act
when a State-licensed nuclear pharmacy, Federal facility, or other
facility that is not an outsourcing facility and that holds a
radioactive materials license for medical use issued by the Nuclear
Regulatory Commission or by an Agreement State compounds or repackages
radiopharmaceuticals for human use.
One of the guidance document's conditions is that the compounded
radiopharmaceutical is not essentially a copy of an approved
radiopharmaceutical. If a compounder intends to rely on a determination
from a prescriber that there is a change between the compounded
radiopharmaceutical and the comparable approved radiopharmaceutical
that produces a clinical difference for an identified individual
patient, either the prescribing practitioner or the compounder
documents the determination on the prescription or order in writing.
This documentation reflects a conversation with the prescribing
practitioner, and the compounder maintains records of the prescription
or order documenting this determination.
In the Federal Register of December 29, 2016 (81 FR 96011), FDA
published a notice of availability for the draft guidance, including a
60-day notice soliciting public comment on the information collection
recommendations. Several comments were received and are discussed
below; however, none of the comments suggested we revise the burden
estimate from our 60-day notice.
(Comment 1) One commenter said documentation of a minor deviation
from an approved radiopharmaceutical should remain at the facility that
performed the minor deviation.
(Response 1) The documentation condition (i.e., documentation of a
prescriber's determination that there is a change that produces a
clinical difference between the compounded radiopharmaceutical and the
comparable FDA-approved radiopharmaceutical for an identified
individual patient) does not apply to compounding that consists only of
minor deviations as defined in the guidance document (i.e., a change
from the approved labeling in radioactivity, volume, or the step-by-
step procedures made when compounding the radiopharmaceutical from an
FDA-approved drug product in a patient-ready dose). The documentation
condition applies to compounding a radiopharmaceutical that involves
manipulation other than minor deviations.
(Comment 2) One commenter supports the requirement for notating
clinical differences, particularly for documenting both the change to
the radiopharmaceutical and the reason that the change is important for
the patient.
(Response 2) FDA concurs with this commenter's views about the
importance of the documentation.
[[Page 32883]]
FDA's guidance document states that the documentation condition would
be met if the prescription for the compounded radiopharmaceutical makes
clear that the prescriber identified the relevant change between the
approved radiopharmaceutical and the compounded radiopharmaceutical and
the clinical difference that the change produces for the patient.
(Comment 3) One commenter recommended that the guidance document
require written documentation when a commercially manufactured
radiopharmaceutical is compounded for a patient because the
radiopharmaceutical is unavailable due to a drug shortage.
(Response 3) The guidance document explains that FDA does not
consider a compounded radiopharmaceutical to be essentially a copy of a
marketed FDA-approved radiopharmaceutical if the FDA-approved
radiopharmaceutical is on FDA's drug shortage list (see section 506E of
the FD&C Act (21 U.S.C. 356e)) at the time of compounding and
distribution. FDA maintains a database for drug shortages. If the
Agency identifies a compounded radiopharmaceutical that has the
characteristics of a drug that is ``essentially a copy,'' FDA intends
to review its database to determine whether there was a shortage of the
approved radiopharmaceutical at the time of compounding and
distribution.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation between the compounder and 10 25 250 0.05 (3 minutes).......................... 12.5
prescriber and the notation on the
prescription or order documenting the
prescriber's determination of clinical
difference.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The total estimated third-party disclosure burden for the guidance
document is shown above.
We estimate that a total of approximately 10 compounders annually
(``No. of Respondents'' in table 1, line 1) will consult a prescriber
to determine whether they decided that the compounded
radiopharmaceutical has a change that produces a clinical difference
for an identified individual patient as compared to the comparable
approved radiopharmaceutical. We estimate that compounders will
document this determination on approximately 250 prescriptions or
orders for compounded radiopharmaceuticals (``Total Annual
Disclosures'' in table 1, line 1). We estimate that the consultation
between the compounder and the prescriber and noting this determination
on each prescription or order that does not already document this
determination will take approximately 3 minutes per prescription or
order.
In the Federal Register of December 29, 2016 (81 FR 96011), FDA
also estimated the annual recordkeeping burden for maintaining records
of prescriptions or orders documenting certain information from
prescribers. While acquiring additional information from the public
about State pharmacy practices since we published 81 FR 96011, FDA has
determined that because the time, effort, and financial resources
necessary to comply with this collection of information would be
incurred by compounders in the normal course of their activities, it is
excluded from the definition of ``burden'' under 5 CFR 1320.3(b)(2).
FDA understands that maintaining records of prescriptions for
compounded drug products is part of the usual course of the practice of
compounding and selling drugs and is required by States' pharmacy laws
and other State laws governing record keeping by healthcare
professionals and healthcare facilities.
Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15095 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P
