83_FR_33018 83 FR 32882 - 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

83 FR 32882 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

Page Range32882-32883
FR Document2018-15095

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.

Federal Register, Volume 83 Issue 136 (Monday, July 16, 2018) 
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32882-32883]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15095]


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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 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.

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: 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

32882 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices https://www.eventbrite.com/e/scientific- FOR FURTHER INFORMATION CONTACT: One of the guidance document’s conference-opioid-and-nicotine-use- Domini Bean, Office of Operations, conditions is that the compounded dependence-and-recovery-influences-of- Food and Drug Administration, Three radiopharmaceutical is not essentially a sex-and-gender-tickets-47087275308. White Flint North, 10A–12M, 11601 copy of an approved Registrants will receive confirmation Landsdown St., North Bethesda, MD radiopharmaceutical. If a compounder and information about accessing the 20852, 301–796–5733, PRAStaff@ intends to rely on a determination from webcast when they have been accepted. fda.hhs.gov. a prescriber that there is a change FDA has verified the website addresses SUPPLEMENTARY INFORMATION: In between the compounded in this document, as of the date this compliance with 44 U.S.C. 3507, FDA radiopharmaceutical and the document publishes in the Federal has submitted the following proposed comparable approved Register, but websites are subject to collection of information to OMB for radiopharmaceutical that produces a change over time. review and clearance. clinical difference for an identified Dated: July 10, 2018. individual patient, either the Guidance for Industry on Compounding prescribing practitioner or the Leslie Kux, and Repackaging of compounder documents the Associate Commissioner for Policy. Radiopharmaceuticals by State- determination on the prescription or [FR Doc. 2018–15096 Filed 7–13–18; 8:45 am] Licensed Nuclear Pharmacies, Federal order in writing. This documentation BILLING CODE 4164–01–P Facilities, and Certain Other Entities reflects a conversation with the OMB Control Number—NEW prescribing practitioner, and the compounder maintains records of the DEPARTMENT OF HEALTH AND This information collection supports prescription or order documenting this HUMAN SERVICES the Agency guidance document entitled determination. ‘‘Guidance for Industry on In the Federal Register of December Food and Drug Administration Compounding and Repackaging of 29, 2016 (81 FR 96011), FDA published Radiopharmaceuticals by State-Licensed a notice of availability for the draft [Docket No. FDA–2016–D–4318] Nuclear Pharmacies, Federal Facilities, guidance, including a 60-day notice and Certain Other Entities.’’ soliciting public comment on the Agency Information Collection Under current law, information collection Activities; Submission for Office of radiopharmaceuticals that are recommendations. Several comments Management and Budget Review; compounded by entities that are not were received and are discussed below; Comment Request; Guidance for registered with FDA as outsourcing however, none of the comments Industry on Compounding and facilities, and radiopharmaceuticals that suggested we revise the burden estimate Repackaging of Radiopharmaceuticals are repackaged, are subject to all from our 60-day notice. by State-Licensed Nuclear Pharmacies, applicable provisions of the Federal (Comment 1) One commenter said Federal Facilities, and Certain Other Food, Drug, and Cosmetic Act (FD&C documentation of a minor deviation Entities Act) related to drug production. Because from an approved radiopharmaceutical Congress explicitly excluded should remain at the facility that AGENCY: Food and Drug Administration, radiopharmaceuticals from section 503A HHS. performed the minor deviation. of the FD&C Act (21 U.S.C. 353a) (see (Response 1) The documentation ACTION: Notice. section 503A(d)(2)), compounded condition (i.e., documentation of a radiopharmaceuticals are not eligible for prescriber’s determination that there is SUMMARY: The Food and Drug the exemptions under section 503A a change that produces a clinical Administration (FDA) is announcing from section 505 of the FD&C Act (21 difference between the compounded that a proposed collection of U.S.C. 355) (concerning new drug radiopharmaceutical and the information has been submitted to the approval requirements), section comparable FDA-approved Office of Management and Budget 502(f)(1) of the FD&C Act (21 U.S.C. radiopharmaceutical for an identified (OMB) for review and clearance under 352(f)(1)) (concerning labeling with individual patient) does not apply to the Paperwork Reduction Act of 1995. adequate directions for use), and section compounding that consists only of DATES: Fax written comments on the 501(a)(2)(B) of the FD&C Act (21 U.S.C. minor deviations as defined in the collection of information by August 15, 351(a)(2)(B)) (concerning current good guidance document (i.e., a change from 2018. manufacturing practice requirements). the approved labeling in radioactivity, ADDRESSES: To ensure that comments on In addition, the FD&C Act does not volume, or the step-by-step procedures the information collection are received, provide an exemption for repackaged made when compounding the OMB recommends that written radiopharmaceuticals. radiopharmaceutical from an FDA- comments be faxed to the Office of FDA developed this guidance approved drug product in a patient- Information and Regulatory Affairs, document to describe the conditions ready dose). The documentation OMB, Attn: FDA Desk Officer, Fax: 202– under which the Agency generally does condition applies to compounding a 395–7285, or emailed to oira_ not intend to take action for violations radiopharmaceutical that involves submission@omb.eop.gov. All of sections 505, 502(f)(1), and manipulation other than minor comments should be identified with the 501(a)(2)(B) of the FD&C Act when a deviations. OMB control number 0910–NEW and State-licensed nuclear pharmacy, (Comment 2) One commenter title ‘‘Guidance for Industry on Federal facility, or other facility that is sradovich on DSK3GMQ082PROD with NOTICES supports the requirement for notating Compounding and Repackaging of not an outsourcing facility and that clinical differences, particularly for Radiopharmaceuticals by State-Licensed holds a radioactive materials license for documenting both the change to the Nuclear Pharmacies, Federal Facilities, medical use issued by the Nuclear radiopharmaceutical and the reason that and Certain Other Entities.’’ Also Regulatory Commission or by an the change is important for the patient. include the FDA docket number found Agreement State compounds or (Response 2) FDA concurs with this in brackets in the heading of this repackages radiopharmaceuticals for commenter’s views about the document. human use. importance of the documentation. VerDate Sep<11>2014 17:31 Jul 13, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\16JYN1.SGM 16JYN1

Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32883 FDA’s guidance document states that documentation when a commercially at the time of compounding and the documentation condition would be manufactured radiopharmaceutical is distribution. FDA maintains a database met if the prescription for the compounded for a patient because the for drug shortages. If the Agency compounded radiopharmaceutical radiopharmaceutical is unavailable due identifies a compounded makes clear that the prescriber to a drug shortage. radiopharmaceutical that has the identified the relevant change between (Response 3) The guidance document characteristics of a drug that is the approved radiopharmaceutical and explains that FDA does not consider a ‘‘essentially a copy,’’ FDA intends to the compounded radiopharmaceutical compounded radiopharmaceutical to be review its database to determine and the clinical difference that the essentially a copy of a marketed FDA- whether there was a shortage of the change produces for the patient. approved radiopharmaceutical if the approved radiopharmaceutical at the (Comment 3) One commenter FDA-approved radiopharmaceutical is time of compounding and distribution. recommended that the guidance on FDA’s drug shortage list (see section FDA estimates the burden of this document require written 506E of the FD&C Act (21 U.S.C. 356e)) collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Number of disclosures Total annual Average burden Type of reporting Total hours respondents per disclosures per disclosure respondent Consultation between the compounder and pre- 10 25 250 0.05 (3 minutes) ........ 12.5 scriber 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 CFR 1320.3(b)(2). FDA understands that (OMB) for review and clearance under disclosure burden for the guidance maintaining records of prescriptions for the Paperwork Reduction Act of 1995. document is shown above. compounded drug products is part of We estimate that a total of the usual course of the practice of DATES: Fax written comments on the approximately 10 compounders compounding and selling drugs and is collection of information by August 15, annually (‘‘No. of Respondents’’ in table required by States’ pharmacy laws and 2018. 1, line 1) will consult a prescriber to other State laws governing record ADDRESSES: To ensure that comments on determine whether they decided that keeping by healthcare professionals and the information collection are received, the compounded radiopharmaceutical healthcare facilities. OMB recommends that written has a change that produces a clinical comments be faxed to the Office of Dated: July 10, 2018. difference for an identified individual Leslie Kux, Information and Regulatory Affairs, patient as compared to the comparable approved radiopharmaceutical. We Associate Commissioner for Policy. OMB, Attn: FDA Desk Officer, Fax: 202– estimate that compounders will [FR Doc. 2018–15095 Filed 7–13–18; 8:45 am] 395–7285, or emailed to oira_ document this determination on BILLING CODE 4164–01–P submission@omb.eop.gov. All approximately 250 prescriptions or comments should be identified with the orders for compounded OMB control number 0910–0594. Also radiopharmaceuticals (‘‘Total Annual DEPARTMENT OF HEALTH AND include the FDA docket number found Disclosures’’ in table 1, line 1). We HUMAN SERVICES in brackets in the heading of this estimate that the consultation between document. the compounder and the prescriber and Food and Drug Administration noting this determination on each FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2012–N–0115] Domini Bean, Office of Operations, prescription or order that does not already document this determination Food and Drug Administration, Three Agency Information Collection will take approximately 3 minutes per Activities; Submission for Office of White Flint North, 10A–12M, 11601 prescription or order. Management and Budget Review; Landsdown St., North Bethesda, MD In the Federal Register of December Comment Request; Guidance for 20852, 301–796–5733, PRAStaff@ 29, 2016 (81 FR 96011), FDA also Industry and FDA Staff—Class II fda.hhs.gov. estimated the annual recordkeeping Special Controls Guidance Document: burden for maintaining records of SUPPLEMENTARY INFORMATION: In Automated Blood Cell Separator compliance with 44 U.S.C. 3507, FDA prescriptions or orders documenting Device Operating by Centrifugal or certain information from prescribers. has submitted the following proposed Filtration Separation Principle While acquiring additional information collection of information to OMB for from the public about State pharmacy AGENCY: Food and Drug Administration, review and clearance. sradovich on DSK3GMQ082PROD with NOTICES practices since we published 81 FR HHS. 96011, FDA has determined that ACTION: Notice. because the time, effort, and financial resources necessary to comply with this SUMMARY: The Food and Drug collection of information would be Administration (FDA or we) is incurred by compounders in the normal announcing that a proposed collection course of their activities, it is excluded of information has been submitted to the from the definition of ‘‘burden’’ under 5 Office of Management and Budget VerDate Sep<11>2014 17:31 Jul 13, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\16JYN1.SGM 16JYN1


Document Created: 2018-07-14 00:54:16
Document Modified: 2018-07-14 00:54:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by August 15, 2018.
ContactDomini 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]
FR Citation83 FR 32882 
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