[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46957-46959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on information collection associated with FDA 
research in obtaining information from medical specialty groups and/or 
medical experts regarding compounded drug products that contain certain 
bulk drug substances to support establishment of a list of bulk drug 
substances under section 503B of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by November 16, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 16, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-2973 for ``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.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: 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 before 
submitting the collection to OMB for approval. To comply with this

[[Page 46958]]

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.

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 FD&C Act requires FDA to develop a list of bulk 
drug substances that may be used in compounding under that section 
(503B bulks list). Compounding includes the combining, admixing, 
mixing, diluting, pooling, reconstituting, or otherwise altering of a 
drug or bulk drug substance to create a drug. If certain conditions 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, labeling with adequate 
directions for use, and drug supply chain security requirements. 
Outsourcing facilities can only use a bulk drug substance to compound 
drugs if: (1) The substance appears on a list developed by FDA of bulk 
drug substances for which there is a clinical need (``bulks list'') or 
(2) the substance is used to compound a drug on FDA's drug shortage 
list 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, ranging in degree of severity from 
treatment of warts to treatment of cancer. To inform our evaluation of 
bulk drug substances for inclusion on the 503B bulks list, we have 
proposed 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. We intend to seek input from the 
CERSI-UMD on the use of these bulk drug substances in clinical practice 
by examining their current and historical use in compounding. 
Information regarding the historical and current use of the substances 
in compounding obtained by this research will help inform our 
assessments as to the clinical need for outsourcing facilities to use 
the substance in compounding.
    FDA's analysis concerning clinical need of nominated bulk drug 
substances consists of two parts. 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 and have successfully completed part 1. 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.''
    As needed, researchers will also engage outsourcing facilities that 
have compounded using the bulk drug substance. Researchers may use 
surveys, interviews, focus groups, and other information collect tools, 
as appropriate, to obtain information concerning the use of compounded 
product(s) from medical experts and outsourcing facilities. Within this 
context, the following questions may be posed:
    1. What are the health conditions 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 drugs using the 
bulk drug substance (e.g., dosage form, strength, route of 
administration)?
    3. Is the compounded drug considered standard therapy by healthcare 
practitioners, and 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)?
    9. What, if any, information exists regarding the effectiveness of 
the compounded drug product in treating the specified health condition?
    We estimate the burden of the collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                       Information collection                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Focus groups and interviews........................................             150               10            1,500                2            3,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 46959]]

    We base our estimate of the average burden per response on review 
activities familiar to the Agency. Noting that 2 hours per response is 
a significant amount of time, we are particularly interested in 
feedback regarding this estimate, including comments regarding how an 
alternative estimate might be derived.

    Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20092 Filed 9-14-18; 8:45 am]
 BILLING CODE 4164-01-P