83 FR 8485 - Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 39 (February 27, 2018)

Page Range		8485-8487
FR Document		2018-03961

The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation.'' The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity FDA should consider when approving a product with a tissue agnostic indication.

Federal Register, Volume 83 Issue 39 (Tuesday, February 27, 2018)

[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8485-8487]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03961]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0663]


Tissue Agnostic Therapies in Oncology: Regulatory Considerations 
for Orphan Drug Designation; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the following public workshop entitled ``Tissue Agnostic 
Therapies in Oncology: Regulatory Considerations for Orphan Drug 
Designation.'' The purpose of the public workshop is to discuss factors 
FDA should consider when evaluating drugs for orphan designation that 
treat a tissue agnostic disease or condition in oncology, and 
additional factors related to orphan exclusivity FDA should consider 
when approving a product with a tissue agnostic indication.

DATES: The public workshop will be held on May 9, 2018, from 9 a.m. to 
5 p.m. The public workshop may be extended or may end early depending 
on the level of public participation. Submit either electronic or 
written comments on this public workshop by June 8, 2018. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. 
Entrance for the public workshop participants (non-FDA employees) is 
through Building 1, where routine security check procedures will be 
performed. For parking and security information, please refer to 
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 June 8, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of June 8, 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

[[Page 8486]]

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-0663 for ``Tissue Agnostic Therapies in Oncology: Regulatory 
Considerations for Orphan Drug Designation; Public Workshop; Request 
for Comments.'' 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.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.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Office of Orphan 
Products Development, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5210, Silver Spring, MD 20933, 301-796-6570, 
OOPDOrphanEvents@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The combination of government incentives, scientific advances, and 
the promise of commercial opportunity has fueled extraordinary 
investment in orphan drugs. Since the Orphan Drug Act was first passed 
in 1983, over 650 rare disease indications for drugs and biologics have 
been developed and approved for marketing. In fact, rare disease drug 
approvals have accounted for approximately 40 percent of the new 
molecular entities and therapeutic biologic products in the Center for 
Drug Evaluation and Research for the last several years.
    Not only have we seen tremendous growth in the development of 
products for rare diseases, but the very landscape of rare disease 
product development is changing, with an increase in the development of 
targeted therapies, more interest in the development of biologics 
(including gene therapies), and tremendous growth in the oncology 
space. For example, in 2017 alone, FDA granted its first tissue 
agnostic approval (pembrolizumab for patients with unresectable or 
metastatic, microsatellite instability-high (MSI-H) or mismatch repair 
deficient (dMMR) solid tumors) and first tissue agnostic orphan drug 
designations (larotrectinib and entrectinib, each for the treatment of 
solid tumors with NTRK-fusion proteins). FDA also approved the first 
cell-based gene therapy, KYMRIAH, for use in treating a rare pediatric 
cancer.
    As advancements in genomics and precision medicine continue, FDA 
has been taking these new developments into account as it considers 
what constitutes a ``disease or condition.'' For example, one question 
that has already arisen in oncology is whether a disease should be 
defined in a tissue/organ-specific or a tissue agnostic manner. Because 
the continued development of targeted therapies for molecularly defined 
groups has the potential to alter the landscape of orphan drug 
development, FDA is holding the public workshop to obtain input on the 
complex scientific and regulatory issues surrounding molecularly 
targeted drugs and biologics in oncology and the appropriate 
application of orphan drug incentives in that paradigm. This discussion 
will inform how the Agency can incorporate the latest science and drug 
development trends into the implementation of the Orphan Drug Act, all 
while continuing to reflect the goals intended by Congress.

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of both presentations and 
interactive panel discussions. The presentations will provide 
information to outline the goals of the workshop and help promote 
interactive discussions. Following the presentations, there will be a 
moderated discussion where speakers and additional panelists will be 
asked to provide their individual perspectives. The presentations and 
discussions will focus on several related topics. Topics will involve 
discussion of and seek input on factors FDA should consider when 
evaluating drugs for orphan designation that treat a tissue agnostic 
disease or condition in oncology and additional factors related to 
orphan exclusivity to consider when approving a product with a tissue 
agnostic indication. A detailed agenda will be posted on the following 
website in advance of the workshop: https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website by April 25, 2018: https://

[[Page 8487]]

www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by April 25, 2018, 5 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive confirmation when their registration has been 
received. If time and space permit, onsite registration on the day of 
the public workshop will be provided beginning an hour prior to the 
start of the meeting.
    If you need special accommodations due to a disability, please 
contact Nicole Wolanski, at 301-796-6570, or 
OOPDOrphanEvents@fda.hhs.gov no later than April 25, 2018.
    An agenda for the workshop and any other background materials will 
be made available 5 days before the workshop at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.
    Streaming Webcast of the Public Workshop: For those unable to 
attend in person, FDA will provide a live webcast of the workshop. To 
register for the streaming webcast of the public workshop, please visit 
the following website by May 8, 2018: https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. 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.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.

    Dated: February 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03961 Filed 2-26-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices 8485

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Mandatory Grant Financial Report .................................................................. 900 4 5 18,000

Estimated Total Annual Burden abbreviated new drug applications from Considerations for Orphan Drug
Hours: multiple applicants, withdrawn as of Designation.’’ The purpose of the public
July 21, 2017. The document indicated workshop is to discuss factors FDA
Additional Information
that FDA was withdrawing approval of should consider when evaluating drugs
Copies of the proposed collection may NDA 204508, Clinolipid 20% (olive oil for orphan designation that treat a tissue
be obtained by writing to the and soybean oil) USP, 16%/4%, after agnostic disease or condition in
Administration for Children and receiving a request from the NDA oncology, and additional factors related
Families, Office of Planning, Research holder, Baxter Healthcare Corp. (Baxter), to orphan exclusivity FDA should
and Evaluation, 330 C Street SW, 32650 N Wilson Rd., Round Lake, IL consider when approving a product
Washington, DC 20201. Attention 60073. Before the approval of NDA with a tissue agnostic indication.
Reports Clearance Officer. All requests 204508 was withdrawn, Baxter DATES: The public workshop will be
should be identified by the title of the informed FDA that it did not want the held on May 9, 2018, from 9 a.m. to 5
information collection. Email address: approval of this NDA withdrawn. p.m. The public workshop may be
infocollection@acf.hhs.gov. Because Baxter timely requested that extended or may end early depending
OMB Comment approval of this NDA not be withdrawn, on the level of public participation.
the approval of NDA 204508 is still in Submit either electronic or written
OMB is required to make a decision effect. comments on this public workshop by
concerning the collection of information June 8, 2018. See the SUPPLEMENTARY
FOR FURTHER INFORMATION CONTACT:
between 30 and 60 days after INFORMATION section for registration date
publication of this document in the Florine Purdie, Center for Drug
Evaluation and Research, Food and and information.
Federal Register. Therefore, a comment ADDRESSES: The public workshop will
is best assured of having its full effect Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, be held at the FDA White Oak Campus,
if OMB receives it within 30 days of 10903 New Hampshire Ave., Building
publication. Written comments and Silver Spring, MD 20993–0002, 301–
796–3601. 31 Conference Center, the Great Room
recommendations for the proposed (Rm. 1503, Section A), Silver Spring,
information collection should be sent SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, June 21, MD 20993–0002. Entrance for the public
directly to the following: Office of workshop participants (non-FDA
Management and Budget, Paperwork 2017, appearing on page 28322 in FR
Doc. 2017–12908, the following employees) is through Building 1, where
Reduction Project, Email: OIRA_ routine security check procedures will
SUBMISSION@OMB.EOP.GOV. Attn: correction is made:
On page 28329, in table 1, the entry be performed. For parking and security
Desk Officer for the Administration for information, please refer to https://www.
Children and Families. for NDA 204508 is removed.
fda.gov/AboutFDA/WorkingatFDA/
Dated: February 21, 2018. BuildingsandFacilities/WhiteOak
Robert Sargis,
Leslie Kux, CampusInformation/ucm241740.htm.
Reports Clearance Officer.
Associate Commissioner for Policy. You may submit comments as
[FR Doc. 2018–03976 Filed 2–26–18; 8:45 am]
[FR Doc. 2018–03925 Filed 2–26–18; 8:45 am] follows. Please note that late, untimely
BILLING CODE P
BILLING CODE 4164–01–P filed comments will not be considered.
Electronic comments must be submitted
DEPARTMENT OF HEALTH AND on or before June 8, 2018. The https://
HUMAN SERVICES DEPARTMENT OF HEALTH AND www.regulations.gov electronic filing
HUMAN SERVICES system will accept comments until
Food and Drug Administration midnight Eastern Time at the end of
Food and Drug Administration June 8, 2018. Comments received by
[Docket No. FDA–2017–N–3203] mail/hand delivery/courier (for written/
[Docket No. FDA–2018–N–0663]
Wyeth Pharmaceuticals Inc. et al.; paper submissions) will be considered
Withdrawal of Approval of 121 New Tissue Agnostic Therapies in timely if they are postmarked or the
Drug Applications and 161 Abbreviated Oncology: Regulatory Considerations delivery service acceptance receipt is on
New Drug Applications; Correction for Orphan Drug Designation; Public or before that date.
Workshop; Request for Comments Electronic Submissions
AGENCY: Food and Drug Administration,
HHS. AGENCY: Food and Drug Administration, Submit electronic comments in the
ACTION: Notice; correction. HHS. following way:
ACTION: Notice of public workshop; • Federal eRulemaking Portal:
daltland on DSKBBV9HB2PROD with NOTICES

SUMMARY: The Food and Drug request for comments. https://www.regulations.gov. Follow the
Administration (FDA) is correcting a instructions for submitting comments.
notice that appeared in the Federal SUMMARY: The Food and Drug Comments submitted electronically,
Register of June 21, 2017 (82 FR 28322). Administration (FDA or the Agency) is including attachments, to https://
The document announced the announcing the following public www.regulations.gov will be posted to
withdrawal of approval of 121 new drug workshop entitled ‘‘Tissue Agnostic the docket unchanged. Because your
applications (NDAs) and 161 Therapies in Oncology: Regulatory comment will be made public, you are

VerDate Sep<11>2014 19:49 Feb 26, 2018 Jkt 244001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1

Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices 8487

www.fda.gov/NewsEvents/Meetings Dated: February 22, 2018. information about the December 20,
ConferencesWorkshops/ Leslie Kux, 2016, updates, please see https://
ucm592778.htm. Please provide Associate Commissioner for Policy. www.federalregister.gov/documents/
complete contact information for each [FR Doc. 2018–03961 Filed 2–26–18; 8:45 am] 2016/12/27/2016-31129/updating-the-
attendee, including name, title, BILLING CODE 4164–01–P
hrsa-supported-womens-preventive-
affiliation, address, email, and services-guidelines. In addition, the
telephone. December 20, 2016, updates, including
DEPARTMENT OF HEALTH AND information related to coverage of
Registration is free and based on
HUMAN SERVICES contraceptive services and exemption
space availability, with priority given to
for objecting organizations from
early registrants. Persons interested in
Health Resources and Service requirements related to the provision of
attending this public workshop must
Administration contraceptive services, can be found at
register by April 25, 2018, 5 p.m.
https://www.hrsa.gov/womens-
Eastern Time. Early registration is Women’s Preventive Services guidelines-2016/index.html.
recommended because seating is Guidelines Information regarding the two new
limited; therefore, FDA may limit the services that were accepted by the
number of participants from each AGENCY: Health Resources and Services
Administration (HRSA), Department of HRSA Administrator on December 29,
organization. Registrants will receive 2017, is set out below:
confirmation when their registration has Health and Human Services (HHS).
been received. If time and space permit, ACTION: Notice. 1. Screening for Diabetes Mellitus After
onsite registration on the day of the Pregnancy
SUMMARY: Applicable as of December 29,
public workshop will be provided The Women’s Preventive Services
2017, HRSA updated the HRSA-
beginning an hour prior to the start of supported Women’s Preventive Services Initiative recommends women with a
the meeting. Guidelines for purposes of health history of gestational diabetes mellitus
If you need special accommodations insurance coverage for preventive (GDM) who are not currently pregnant
due to a disability, please contact Nicole services that address health needs and who have not previously been
Wolanski, at 301–796–6570, or specific to women based on clinical diagnosed with type 2 diabetes mellitus
OOPDOrphanEvents@fda.hhs.gov no recommendations from the Women’s should be screened for diabetes
later than April 25, 2018. Preventive Services Initiative. This 2017 mellitus. Initial testing should ideally
update adds two additional services— occur within the first year postpartum
An agenda for the workshop and any
Screening for Diabetes Mellitus after and can be conducted as early as 4–6
other background materials will be
Pregnancy and Screening for Urinary weeks postpartum.
made available 5 days before the Women with a negative initial
workshop at https://www.fda.gov/News Incontinence—to the nine preventive
services included in the 2016 update to postpartum screening test result should
Events/MeetingsConferencesWorkshops/ be rescreened at least every 3 years for
ucm592778.htm. the HRSA-supported Women’s
Preventive Services Guidelines. The a minimum of 10 years after pregnancy.
Streaming Webcast of the Public nine services included in the 2016 For women with a positive postpartum
Workshop: For those unable to attend in update are as follows: Breast Cancer screening test result, testing to confirm
person, FDA will provide a live webcast Screening for Average Risk Women, the diagnosis of diabetes is indicated
of the workshop. To register for the Breastfeeding Services and Supplies, regardless of the initial test (e.g., oral
streaming webcast of the public Screening for Cervical Cancer, glucose tolerance test, fasting plasma
workshop, please visit the following Contraception, Screening for Gestational glucose, or hemoglobin A1c). Repeat
website by May 8, 2018: https://www. Diabetes Mellitus, Screening for Human testing is indicated in women who were
fda.gov/NewsEvents/Meetings Immunodeficiency Virus Infection, screened with hemoglobin A1c in the
ConferencesWorkshops/ Screening for Interpersonal and first six months postpartum regardless
ucm592778.htm. Domestic Violence, Counseling for of the result (see Implementation
If you have never attended a Connect Sexually Transmitted Infections, and Considerations below).
Pro event before, test your connection at Well-Woman Preventive Visits. This 2. Screening for Urinary Incontinence
https://collaboration.fda.gov/common/ notice serves as an announcement of the The Women’s Preventive Services
help/en/support/meeting_test.htm. To decision to update the guidelines as Initiative recommends screening women
get a quick overview of the Connect Pro listed below. Please see https:// for urinary incontinence annually.
program, visit https://www.adobe.com/ www.hrsa.gov/womens-guidelines/ Screening should ideally assess whether
go/connectpro_overview. FDA has index.html for additional information. women experience urinary incontinence
verified the website addresses in this FOR FURTHER INFORMATION CONTACT: and whether it impacts their activities
document, as of the date this document Kimberly C. Sherman, Maternal and and quality of life. The Women’s
publishes in the Federal Register, but Child Health Bureau, HRSA at phone: Preventive Services Initiative
websites are subject to change over time. (301) 443–0543; email: wellwomancare@ recommends referring women for
Transcripts: Please be advised that as hrsa.gov. further evaluation and treatment if
soon as a transcript of the public SUPPLEMENTARY INFORMATION: The indicated.
workshop is available, it will be complete set of updated 2017 HRSA-
accessible at https:// supported Women’s Preventive Services HRSA-Supported Women’s Preventive
daltland on DSKBBV9HB2PROD with NOTICES

www.regulations.gov. It may be viewed Guidelines includes those that were Services Guidelines
at the Dockets Management Staff (see accepted by the Acting HRSA The HRSA-supported Women’s
ADDRESSES). A link to the transcript will Administrator on December 20, 2016, as Preventive Services Guidelines were
also be available on the internet at well as two new services, Screening for originally established in 2011 based on
https://www.fda.gov/NewsEvents/ Diabetes Mellitus After Pregnancy and recommendations from an HHS
MeetingsConferencesWorkshops/ Screening for Urinary Incontinence. For commissioned study by the Institute of
ucm592778.htm. a complete listing and detailed Medicine, now known as the National

VerDate Sep<11>2014 19:49 Feb 26, 2018 Jkt 244001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1

Document Created: 2018-02-27 01:14:54
Document Modified: 2018-02-27 01:14:54

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 public workshop; request for comments.
Dates		The public workshop will be held on May 9, 2018, from 9 a.m. to 5 p.m. The public workshop may be extended or may end early depending on the level of public participation. Submit either electronic or written comments on this public workshop by June 8, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Contact		Nicole Wolanski, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5210, Silver Spring, MD 20933, 301-796-6570, [email protected]
FR Citation		83 FR 8485

83 FR 8485 - Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 39 (February 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration