Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability, 22270-22271 [2018-10187]

Download as PDF 22270 Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices Estimated Total Annual Burden Hours: 5,211. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@ acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2018–10169 Filed 5–11–18; 8:45 am] BILLING CODE 4184–77–P 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Food and Drug Administration [Docket No. FDA–2018–D–1638] Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Pediatric HIV Infection: Drug Development for Treatment.’’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 DATES: Submit either electronic or written comments on the draft guidance by July 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. amozie on DSK3GDR082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:02 May 11, 2018 Jkt 244001 You may submit comments on any guidance at any time as follows: ADDRESSES: 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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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. 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, E:\FR\FM\14MYN1.SGM 14MYN1 Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices 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: ACTION: 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/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 amozie on DSK3GDR082PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation of Nominations for Membership To Serve on the Council on Graduate Medical Education Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). VerDate Sep<11>2014 18:02 May 11, 2018 Jkt 244001 HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Council on Graduate Medical Education (COGME). COGME provides advice and recommendations to the Secretary of HHS; the Senate Committee on Health, Education, Labor and Pensions; and the U.S. House of Representatives Committee on Energy and Commerce on matters concerning the supply and distribution of physicians in the United States, physician workforce trends, training issues, financing policies, and other matters of significance related to physician workforce and graduate medical education. DATES: The agency will accept nominations on a continuous basis. ADDRESSES: Nomination packages may be mailed to Advisory Council Operations, Bureau of Health Workforce, HRSA, Room 11W45C, 5600 Fishers Lane, Rockville, Maryland 20857 or submitted electronically by email to: BHWAdvisoryCouncilFRN@ hrsa.gov. SUMMARY: I. Background AGENCY: Request for nominations. FOR FURTHER INFORMATION CONTACT: Kennita R. Carter, MD, Designated Federal Official, COGME at 301–945– 3505 or email at kcarter@hrsa.gov. A copy of the current COGME charter, membership, and reports can be obtained by accessing the COGME website https://www.hrsa.gov/advisory committees/bhpradvisory/cogme/. SUPPLEMENTARY INFORMATION: COGME encourages entities providing graduate medical education to conduct activities to voluntarily achieve the recommendations of COGME; develops, publishes, and implements performance measures and longitudinal evaluations; and recommends appropriation levels for certain Public Health Service Act (PHSA) Title VII programs. Meetings take place twice a year. Nominations: HRSA is requesting nominations for voting members of COGME to include representatives of practicing primary care physicians, national and specialty physician organizations, foreign medical graduates, medical student and house staff associations, schools of allopathic and osteopathic medicine, public and private teaching hospitals, and representatives of health insurers, business, and labor. Additionally, HRSA encourages nominations of medical students, residents, and/or fellows. Members receive appointments based on their competence, interest, and knowledge of the mission of the profession involved. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 22271 The Secretary of HHS will consider nominations of all qualified individuals within the areas of subject matter expertise noted above. In making such appointments, the Secretary shall ensure a broad geographic representation of members and a balance between urban and rural educational settings. Professional organizations, employers, or colleagues may nominate one or more qualified persons for membership. Individuals selected for appointment to COGME will be invited to serve for 4 years. COGME members are appointed as special government employees and receive a stipend and reimbursement for per diem and travel expenses incurred for attending meetings and/or conducting other business on behalf of COGME, as authorized by section 5 U.S.C. 5703 for persons employed intermittently in government service. To evaluate possible conflicts of interest, individuals selected for consideration for appointment will be required to provide detailed information regarding their financial holdings, consultancies, and research grants or contracts. The selected candidates must fill out the U.S. Office of Government Ethics (OGE) Confidential Financial Disclosure Report, OGE Form 450. Disclosure of this information is necessary to determine if the selected candidate is involved in any activity that may pose a potential conflict with their official duties as a member of the Committee. A nomination package should include the following information for each nominee: (1) A letter of nomination from an employer, a colleague, or a professional organization stating the name, affiliation, and contact information for the nominee, the basis for the nomination (i.e., what specific attributes, perspectives, and/or skills does the individual possess that would benefit the workings of COGME), and the nominee’s field(s) of expertise; (2) a letter of interest from the nominee stating the reasons they would like to serve on COGME; (3) a biographical sketch of the nominee, including a copy of his/her curriculum vitae and his/her contact information (address, daytime telephone number, and email address); and (4) the name, address, daytime telephone number, and email address where the person nominating the individual can be contacted. HRSA will collect and retain nomination packages to create a pool of possible future COGME voting members. When a vacancy occurs, HRSA may review nomination packages from the appropriate category and may contact nominees at that time. E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 83, Number 93 (Monday, May 14, 2018)]
[Notices]
[Pages 22270-22271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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.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.
    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