83 FR 12952 - Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 58 (March 26, 2018)

Page Range		12952-12953
FR Document		2018-06046

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes policies that FDA proposes to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.

Federal Register, Volume 83 Issue 58 (Monday, March 26, 2018)

[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Notices]
[Pages 12952-12953]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-06046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1067]

Evaluation of Bulk Drug Substances Nominated for Use in
Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic
Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Evaluation of Bulk Drug Substances Nominated for Use in Compounding
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This
draft guidance describes policies that FDA proposes to use in
evaluating bulk drug substances nominated for use in compounding under
section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for
inclusion on the list of bulk drug substances that can be used in
compounding under section 503B.

DATES: Submit either electronic or written comments on the draft
guidance by May 25, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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

[[Page 12953]]

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-D-1067 for ``Evaluation of Bulk Drug Substances Nominated for
Use in Compounding Under Section 503B of the Federal Food, Drug, and
Cosmetic Act.'' Received comments 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.thefederalregister.org/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Evaluation of Bulk Drug Substances Nominated for Use in
Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' Section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug
Quality and Security Act in 2013, describes the conditions that must be
satisfied for human drug products compounded by an outsourcing facility
to be exempt from the following three sections of the FD&C Act: section
505 (21 U.S.C. 355) (concerning the approval of drugs under new drug
applications or abbreviated new drug applications); section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning
drug supply chain security requirements). 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 does not
compound drug products using a bulk drug substance unless either: (1)
It appears on a list established by the Secretary of Health and Human
Services identifying bulk drug substances for which there is a clinical
need (see section 503B(a)(2)(A)(i) of the FD&C Act) (503B Bulks List)
or (2) the drug compounded from such bulk drug substances 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
(see section 503B(a)(2)(A)(ii) of the FD&C Act).
This draft guidance addresses FDA policies for developing the 503B
Bulks List, including the Agency's interpretation of the phrase ``bulk
drug substances for which there is a clinical need,'' as it is used in
section 503B of the FD&C Act. The draft guidance also addresses the
factors and processes by which the Agency intends to evaluate and list
bulk drug substances.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Evaluation
of Bulk Drug Substances Nominated for Use in Compounding Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This draft
guidance is not subject to Executive Order 12866.

II. Electronic Access

Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

Dated: March 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06046 Filed 3-23-18; 8:45 am]
BILLING CODE 4164-01-P

12952 Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Notices

and associated materials (see progress report is used by the national regarding this collection contact Maria
ADDRESSES). evaluation contractor and CMS to Sotirelis at 410–786–0552.)
CMS–10249 Administrative monitor program implementation at the Dated: March 21, 2018.
Requirements for Section 6071 of grantee level. Form Number: CMS– William N. Parham, III,
the Deficit Reduction Act 10249 (OMB control number: 0938– Director, Paperwork Reduction Staff, Office
CMS–10261 Part C Medicare Advantage 1053); Frequency: Yearly, quarterly, and of Strategic Operations and Regulatory
Reporting Requirements and semi-annually; Affected Public: State, Affairs.
Supporting Regulations in 42 CFR Local, or Tribal Governments; Number [FR Doc. 2018–06052 Filed 3–23–18; 8:45 am]
422.516(a) of Respondents: 45; Total Annual BILLING CODE 4120–01–P
Under the PRA (44 U.S.C. 3501– Responses: 28,590; Total Annual Hours:
3520), federal agencies must obtain 14,225. (For policy questions regarding
approval from the Office of Management this collection contact Effie George at DEPARTMENT OF HEALTH AND
and Budget (OMB) for each collection of 410–786–8639.) HUMAN SERVICES
information they conduct or sponsor. 2. Type of Information Collection
The term ‘‘collection of information’’ is Request: Revision of a currently Food and Drug Administration
defined in 44 U.S.C. 3502(3) and 5 CFR approved collection; Title of [Docket No. FDA–2018–D–1067]
1320.3(c) and includes agency requests Information Collection: Part C Medicare
or requirements that members of the Advantage Reporting Requirements and Evaluation of Bulk Drug Substances
public submit reports, keep records, or Supporting Regulations in 42 CFR Nominated for Use in Compounding
provide information to a third party. 422.516(a); Use: Medicare Advantage Under Section 503B of the Federal
Section 3506(c)(2)(A) of the PRA Organizations (MAOs) must have an Food, Drug, and Cosmetic Act; Draft
requires federal agencies to publish a effective procedure to develop, compile, Guidance for Industry; Availability
60-day notice in the Federal Register evaluate, and report to CMS, to its
concerning each proposed collection of AGENCY: Food and Drug Administration,
enrollees, and to the general public, at HHS.
information, including each proposed the times and in the manner that CMS
extension or reinstatement of an existing ACTION: Notice of availability.
requires, and while safeguarding the
collection of information, before confidentiality of the doctor-patient SUMMARY: The Food and Drug
submitting the collection to OMB for relationship, statistics and other Administration (FDA or the Agency) is
approval. To comply with this information with respect to: The cost of announcing the availability of a draft
requirement, CMS is publishing this its operations; the patterns of service guidance for industry entitled
notice.
utilization; the availability, ‘‘Evaluation of Bulk Drug Substances
Information Collection accessibility, and acceptability of its Nominated for Use in Compounding
1. Type of Information Collection services; to the extent practical, Under Section 503B of the Federal
Request: Extension of a currently developments in the health status of its Food, Drug, and Cosmetic Act.’’ This
approved collection; Title of enrollees; information demonstrating draft guidance describes policies that
Information Collection: Administrative that the MAO has a fiscally sound FDA proposes to use in evaluating bulk
Requirements for Section 6071 of the operation; and other matters that CMS drug substances nominated for use in
Deficit Reduction Act; Use: State may require. CMS also has oversight compounding under section 503B of the
Operational Protocols should provide authority over cost plans which Federal Food, Drug, and Cosmetic Act
enough information such that: The CMS includes establishment of reporting (FD&C Act) for inclusion on the list of
Project Officer and other federal officials requirements. The changes for the 2019 bulk drug substances that can be used
may use it to understand the operation reporting requirements under in compounding under section 503B.
of the demonstration, prepare for Organization Determinations and DATES: Submit either electronic or
potential site visits without needing Reconsiderations (ODR) will add 18 written comments on the draft guidance
additional information, or both; the new data elements to the reporting by May 25, 2018 to ensure that the
State Project Director can use it as the section. The new data elements will Agency considers your comment on this
manual for program implementation; allow CMS to obtain more information draft guidance before it begins work on
and external stakeholders may use it to about who is submitting requests for the final version of the guidance.
understand the operation of the ODR and whether the service or claim ADDRESSES: You may submit comments
demonstration. The financial is being provided by a contract or non- on any guidance at any time as follows:
information collection is used in our contract provider. The timeliness
financial statements and shared with the requirement for ODR will also be Electronic Submissions
auditors who validate CMS’ financial eliminated to be consistent with Part D Submit electronic comments in the
position. The Money Follows the Person reporting. In addition, the number of following way:
Rebalancing Demonstration (MFP) data reporting elements of grievances is • Federal eRulemaking Portal:
Finders File, MFP Program Participation reduced from 23 to 19. The reporting https://www.regulations.gov. Follow the
Data file, and MFP Services File are sections for Private Fee For Service instructions for submitting comments.
used by the national evaluation (PFFS) Payment Dispute Resolution Comments submitted electronically,
contractor to assess program outcomes Process and Mid-Year Network Changes including attachments, to https://
while we use the information to monitor will also be suspended. Form Number: www.regulations.gov will be posted to
sradovich on DSK3GMQ082PROD with NOTICES

program implementation. The MFP CMS–10261 (OMB control number: the docket unchanged. Because your
Quality of Life data is used by the 0938–1054); Frequency: Yearly and comment will be made public, you are
national evaluation contractor to assess semi-annually; Affected Public: Private solely responsible for ensuring that your
program outcomes. The evaluation is sector (business or other for-profits); comment does not include any
used to determine how participants’ Number of Respondents: 432; Total confidential information that you or a
quality of life changes after transitioning Annual Responses: 3,024; Total Annual third party may not wish to be posted,
to the community. The semi-annual Hours: 127,329. (For policy questions such as medical information, your or

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Document Created: 2018-03-24 01:00:03
Document Modified: 2018-03-24 01:00:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796- 3110.
FR Citation		83 FR 12952

83 FR 12952 - Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 58 (March 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration