Document ID: FDA-2018-N-2973-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2019-05-08T04:00Z

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20137-20138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09414]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2973]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Obtaining Information 
for Evaluating Nominated Bulk Drug Substances for Use in Compounding 
Drug Products Under Section 503B of the Federal Food, Drug, and 
Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 June 7, 
2019.

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 ``Obtaining Information for Evaluating Nominated Bulk Drug 
Substances for Use in Compounding Drug Products Under Section 503B of 
the Federal Food, Drug, and Cosmetic Act.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
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.

Clinical Use of Bulk Drug Substances Nominated for Use in Compounding 
by Outsourcing Facilities OMB Control Number 0910--NEW

    This information collection supports Agency-sponsored research. 
Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 353b) requires FDA to develop a list of bulk drug substances 
that may be used in compounding under that section (503B bulks list). 
Section 503B defines compounding to include the combining, admixing, 
mixing, diluting, pooling, reconstituting, or otherwise altering of a 
drug or bulk drug substance to create a drug. Compounded drugs are not 
FDA-approved. If the conditions under section 503B are met, drug 
products compounded by entities known as outsourcing facilities are 
exempt from the following requirements of the FD&C Act: requirements 
for FDA approval of drugs in section 505 of the FD&C Act (21 U.S.C. 
355), labeling with adequate directions for use under section 502(f)(1) 
of the FD&C Act (21 U.S.C. 352(f)(1)), and drug supply chain security 
requirements under section 582 (21 U.S.C. 360eee-1). One of the 
conditions that must be met for a drug product compounded by an 
outsourcing facility to qualify for these exemptions is that the 
outsourcing facility may not compound a drug using a bulk drug 
substance unless (1) the bulk drug substance appears on a list 
established by the Secretary identifying bulk drug substances for which 
there is a clinical need (``bulks list''); or (2) the substance appears 
on the drug shortage list in effect under section 506E of the FD&C Act 
(21 U.S.C. 356e) at the time of compounding, distribution, and 
dispensing.
    Many bulk drug substances have been nominated by the public for use 
in compounding by outsourcing facilities with adequate supporting 
information for FDA to evaluate them. The substances were nominated to 
treat a variety of conditions. To inform our evaluation of bulk drug 
substances for inclusion on the 503B bulks list, we have entered into a 
research study with the University of Maryland (UMD) Center of 
Excellence in Regulatory Science and Innovation (CERSI) and the Johns 
Hopkins University (JHU) CERSI.
    FDA intends to use a two-part analysis in evaluating substances 
nominated for placement on the 503B bulks list to determine whether 
there is a clinical need. The collaboration with CERSI-UMD and CERSI-
JHU pertains to part 2 of the analysis, which applies to bulk drug 
substances that are not components of FDA-approved drug products, as 
well as certain bulk drug substances that are components of FDA-
approved drug products that have gone through part 1 and warrant 
further evaluation under part 2 of the analysis. One of the factors 
that FDA considers under part 2 is ``current and historical use of the 
substance in compounded drug products, including information about the 
medical condition(s) that the substance has been used to treat and any 
references in peer-reviewed medical literature.''
    Researchers may use surveys, interviews, focus groups, and other

[[Page 20138]]

information collect tools, as appropriate, to obtain information 
concerning the use of compounded product(s) from medical experts, 
outsourcing facilities, and other stakeholders. Within this context, 
the following questions may be posed:
    1. What are the health condition(s) that the compounded drug is 
currently and has been historically used to treat? What is the patient 
population for which the compound drug has been used to treat?
    2. What are the characteristics of the compounded drug(s) using the 
bulk drug substance (e.g., dosage form, strength, route of 
administration)?
    3. Is the compounded drug considered standard therapy by healthcare 
practitioners, or is it recommended in clinical practice guidelines? If 
so, under what circumstances?
    4. Does an approved drug exist for the health condition that the 
compounded drug product is used to treat? If so, what are the 
circumstances under which a compounded drug product using the bulk drug 
substance would be used in lieu of the approved drug product?
    5. What is the historical use of the compounded drug to treat the 
health conditions identified, including the number of years during 
which the compounded drug has been prescribed for each use, and any 
change regarding its use over time?
    6. To what extent do practitioners prescribe the compounded drug to 
treat each health condition identified? How many such prescriptions 
and/or orders have been written in the past 5 years? Have there been 
any notable changes in the number of prescriptions and/or orders 
written over this time?
    7. How widespread is the use of the compounded drug product, 
including use in other countries?
    8. Do practitioners order the compounded drug to maintain on hand 
before a patient presents with a need for the drug (``office stock''), 
or do practitioners typically write prescriptions for a patient after 
the patient presents with a need for the compounded drug? If the 
former, why (e.g., emergency situations, convenience)?
    In the Federal Register of September 17, 2018 (83 FR 46957), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received, and FDA determined 
that this comment was applicable to a different docket published in the 
Federal Register, and not relevant to this proposed collection of 
mation.
    We estimate the burden of the collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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UMD-CERSI Expert Focus Groups                150              10           1,500               2           3,000
 and Interviews.................
UMD-CERSI Expert Questionnaire..             750              10           7,500           * 0.5           3,750
JHU-CERSI Parent Questionnaire..           1,000               1           1,000           * 0.5             500
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    Total.......................           7,250
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
* 30 minutes.

    We base our estimate of the average burden per response on review 
activities familiar to the Agency. Since issuing the 60-day notice, FDA 
determined an additional burden estimate related to completion of 
questionnaires. We welcome additional comments regarding this estimate.

    Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09414 Filed 5-7-19; 8:45 am]
BILLING CODE 4164-01-P