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, 46957-46959 [2018-20092]
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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices
Authority: Section 1110 of the Social
Security Act.
Electronic Submissions
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–20068 Filed 9–14–18; 8:45 am]
BILLING CODE 4184–07–P
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.
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.
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SUMMARY:
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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
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46957
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/201523389.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, PRAStaff@
fda.hhs.gov.
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
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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices
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 FDAapproved 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:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Information collection
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Focus groups and interviews ...............................................
150
10
1,500
2
3,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices
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.
Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20091 Filed 9–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3236]
[FR Doc. 2018–20092 Filed 9–14–18; 8:45 am]
Advisory Committee; Oncologic Drugs
Advisory Committee; Renewal
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice; renewal of advisory
committee.
ACTION:
Food and Drug Administration
The Food and Drug
Administration (FDA) is announcing the
renewal of the Oncologic Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Oncologic Drugs
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until September 1, 2020.
DATES: Authority for the Oncologic
Drugs Advisory Committee will expire
on September 1, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Lauren Tesh, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, email:
ODAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Oncologic Drugs Advisory Committee.
The committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Oncologic Drugs Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
FDA has regulatory responsibility.
The committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cancer and
makes appropriate recommendations to
the Commissioner.
SUMMARY:
[Docket No. FDA–2018–N–3431]
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Anesthetic and Analgesic Drug
Products Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments’’ that
appeared in the Federal Register of
September 11, 2018. The document
announced a forthcoming public
advisory committee meeting of the
Anesthetic and Analgesic Drug Products
Advisory Committee and establishment
of a public docket for comments. The
document was published with the
incorrect docket number. This
document corrects that error.
SUMMARY:
Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of Tuesday, September
11, 2018 (83 FR 45941), in FR Doc.
2018–19667, on page 45941, the
following correction is made:
On page 45941, in the first column, in
the header of the document, and also in
the third column under Instructions,
‘‘Docket No. FDA–2018–N–3276’’ is
corrected to read ‘‘Docket No. FDA–
2018–N–3431’’.
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SUPPLEMENTARY INFORMATION:
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The committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of general
oncology, pediatric oncology,
hematologic oncology, immunology
oncology, biostatistics, and other related
professions. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
OncologicDrugsAdvisoryCommittee/
ucm107395.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20108 Filed 9–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0001]
Pathogen Reduction Technologies for
Blood Safety; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Pathogen Reduction Technologies for
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
