83 FR 22270 - Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 93 (May 14, 2018)

Page Range		22270-22271
FR Document		2018-10187

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric HIV Infection: Drug Development for Treatment.'' This guidance provides general recommendations on the development of drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age).

Federal Register, Volume 83 Issue 93 (Monday, May 14, 2018)

[Federal Register Volume 83, Number 93 (Monday, May 14, 2018)]
[Notices]
[Pages 22270-22271]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-10187]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1638]

Pediatric HIV Infection: Drug Development for Treatment; Draft
Guidance for Industry; Availability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 Agency) is announcing
the availability of a draft guidance for industry entitled ``Pediatric
HIV Infection: Drug Development for Treatment.'' This guidance provides
general recommendations on the development of drug products for the
treatment of human immunodeficiency virus (HIV) infection in pediatric
patients (birth to younger than 17 years of age).

DATES: Submit either electronic or written comments on the draft
guidance by July 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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-1638 for ``Pediatric HIV Infection: Drug Development for
Treatment; Draft Guidance for Industry; Availability.'' 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; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Building 71, Rm. 3128, 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: Yodit Belew, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6322, Silver Spring,

[[Page 22271]]

MD 20993-0002, 301-796-1500; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Pediatric HIV Infection: Drug Development for Treatment.''
This draft guidance provides general recommendations on the development
of products for the treatment of human immunodeficiency virus (HIV)
infection in pediatric patients (birth to younger than 17 years of
age), including recommendations on when sponsors should initiate
pediatric formulation development and begin pediatric studies to
evaluate antiretroviral drug products for the treatment of HIV
infection.
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 drug
development for treatment of pediatric HIV infection. 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 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, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10187 Filed 5-11-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices 22271

MD 20993–0002, 301–796–1500; or ACTION: Request for nominations. The Secretary of HHS will consider
Stephen Ripley, Center for Biologics nominations of all qualified individuals
Evaluation and Research, Food and SUMMARY: HRSA is seeking nominations within the areas of subject matter
Drug Administration, 10903 New of qualified candidates for consideration expertise noted above. In making such
Hampshire Ave., Bldg. 71, Rm. 7301, for appointment as members of the appointments, the Secretary shall
Silver Spring, MD 20993–0002, 240– Council on Graduate Medical Education ensure a broad geographic
402–7911. (COGME). COGME provides advice and representation of members and a
recommendations to the Secretary of balance between urban and rural
SUPPLEMENTARY INFORMATION:
HHS; the Senate Committee on Health, educational settings.
I. Background Education, Labor and Pensions; and the Professional organizations, employers,
FDA is announcing the availability of U.S. House of Representatives or colleagues may nominate one or more
a draft guidance for industry entitled Committee on Energy and Commerce on qualified persons for membership.
‘‘Pediatric HIV Infection: Drug matters concerning the supply and Individuals selected for appointment to
Development for Treatment.’’ This draft distribution of physicians in the United COGME will be invited to serve for 4
guidance provides general States, physician workforce trends, years. COGME members are appointed
recommendations on the development training issues, financing policies, and as special government employees and
other matters of significance related to receive a stipend and reimbursement for
of products for the treatment of human
physician workforce and graduate per diem and travel expenses incurred
immunodeficiency virus (HIV) infection
medical education. for attending meetings and/or
in pediatric patients (birth to younger
DATES: The agency will accept conducting other business on behalf of
than 17 years of age), including
nominations on a continuous basis. COGME, as authorized by section 5
recommendations on when sponsors
U.S.C. 5703 for persons employed
should initiate pediatric formulation ADDRESSES: Nomination packages may intermittently in government service.
development and begin pediatric be mailed to Advisory Council To evaluate possible conflicts of
studies to evaluate antiretroviral drug Operations, Bureau of Health interest, individuals selected for
products for the treatment of HIV Workforce, HRSA, Room 11W45C, 5600 consideration for appointment will be
infection. Fishers Lane, Rockville, Maryland required to provide detailed information
This draft guidance is being issued 20857 or submitted electronically by regarding their financial holdings,
consistent with FDA’s good guidance email to: BHWAdvisoryCouncilFRN@ consultancies, and research grants or
practices regulation (21 CFR 10.115). hrsa.gov. contracts. The selected candidates must
The draft guidance, when finalized, will fill out the U.S. Office of Government
FOR FURTHER INFORMATION CONTACT:
represent the current thinking of FDA Ethics (OGE) Confidential Financial
on drug development for treatment of Kennita R. Carter, MD, Designated
Federal Official, COGME at 301–945– Disclosure Report, OGE Form 450.
pediatric HIV infection. It does not Disclosure of this information is
establish any rights for any person and 3505 or email at kcarter@hrsa.gov. A
copy of the current COGME charter, necessary to determine if the selected
is not binding on FDA or the public. candidate is involved in any activity
You can use an alternative approach if membership, and reports can be
obtained by accessing the COGME that may pose a potential conflict with
it satisfies the requirements of the their official duties as a member of the
applicable statutes and regulations. This website https://www.hrsa.gov/advisory
committees/bhpradvisory/cogme/. Committee.
guidance is not subject to Executive A nomination package should include
Order 12866. SUPPLEMENTARY INFORMATION: COGME the following information for each
encourages entities providing graduate nominee: (1) A letter of nomination
II. Electronic Access medical education to conduct activities from an employer, a colleague, or a
Persons with access to the internet to voluntarily achieve the professional organization stating the
may obtain the draft guidance at either recommendations of COGME; develops, name, affiliation, and contact
https://www.fda.gov/Drugs/Guidance publishes, and implements performance information for the nominee, the basis
ComplianceRegulatoryInformation/ measures and longitudinal evaluations; for the nomination (i.e., what specific
Guidances/default.htm, https:// and recommends appropriation levels attributes, perspectives, and/or skills
www.fda.gov/BiologicsBloodVaccines/ for certain Public Health Service Act does the individual possess that would
GuidanceComplianceRegulatory (PHSA) Title VII programs. Meetings benefit the workings of COGME), and
Information/Guidances/default.htm, or take place twice a year. the nominee’s field(s) of expertise; (2) a
https://www.regulations.gov. Nominations: HRSA is requesting letter of interest from the nominee
Dated: May 7, 2018. nominations for voting members of stating the reasons they would like to
Leslie Kux,
COGME to include representatives of serve on COGME; (3) a biographical
practicing primary care physicians, sketch of the nominee, including a copy
Associate Commissioner for Policy.
national and specialty physician of his/her curriculum vitae and his/her
[FR Doc. 2018–10187 Filed 5–11–18; 8:45 am]
organizations, foreign medical contact information (address, daytime
BILLING CODE 4164–01–P graduates, medical student and house telephone number, and email address);
staff associations, schools of allopathic and (4) the name, address, daytime
and osteopathic medicine, public and telephone number, and email address
DEPARTMENT OF HEALTH AND private teaching hospitals, and where the person nominating the
HUMAN SERVICES representatives of health insurers, individual can be contacted.
amozie on DSK3GDR082PROD with NOTICES

Solicitation of Nominations for business, and labor. Additionally, HRSA HRSA will collect and retain
Membership To Serve on the Council encourages nominations of medical nomination packages to create a pool of
on Graduate Medical Education students, residents, and/or fellows. possible future COGME voting
Members receive appointments based members. When a vacancy occurs,
AGENCY: Health Resources and Services on their competence, interest, and HRSA may review nomination packages
Administration (HRSA), Department of knowledge of the mission of the from the appropriate category and may
Health and Human Services (HHS). profession involved. contact nominees at that time.

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Document Created: 2018-05-12 01:10:53
Document Modified: 2018-05-12 01:10:53

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 July 13, 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		Yodit Belew, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6322, Silver Spring, MD 20993-0002, 301-796-1500; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
FR Citation		83 FR 22270

83 FR 22270 - Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 93 (May 14, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration