32882 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

https://www.eventbrite.com/e/scientificconference-opioid-and-nicotine-usedependence-and-recovery-influences-ofsex-and-gender-tickets-47087275308. 

Registrants will receive confirmation 

and information about accessing the 

webcast when they have been accepted. 

FDA has verified the website addresses 

in this document, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

Dated: July 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[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. 

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 StateLicensed 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 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. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 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 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)) 

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

Type of reporting Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Consultation between the compounder and prescriber and the notation on the prescription or 

order documenting the prescriber’s determination 

of clinical difference.

10 25 250 0.05 (3 minutes) ........ 12.5 

1There 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[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, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

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 0910–0594. 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. 


sradovich on DSK3GMQ082PROD with NOTICES