Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans; Availability, 42085-42086 [2013-16825]

Download as PDF Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Notices regional, and global level. Engaging the STDF through this cooperative agreement will provide FDA with ample opportunities to leverage additional resources among WTO member countries. Overall, the objectives of the STDF are directly in line with the objectives of this cooperative agreement. This ability to advance the objectives of this cooperative agreement through member country engagement and leveraging is a requisite for success. B. Research Objectives The purpose of this cooperative agreement is to: 1. Contribute to the knowledge base and development of food safety systems globally due to the increasingly diverse and complex food supply; 2. Enhance and broaden FDA’s ability to address global food safety and public health issues associated with food; 3. Provide opportunities to leverage additional resources among WTO member countries; 4. Support FDA’s Food Safety Modernization Act (FSMA) and its International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safetyrelated problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety. tkelley on DSK3SPTVN1PROD with NOTICES problems rather than merely reacting to problems after they occur. FDA recognizes that it cannot do this alone. By leveraging with other WTO member countries and partnering with the STDF, FDA can broaden the reach of food safety capacity building efforts. This cooperative agreement will allow FDA to deepen its international food safety capacity building partnerships, provide a wider scope of impact than exists currently and leverage resources with other countries. II. Award Information/Funds Available C. Eligibility Information Competition is limited to the STDF hosted by the WTO. The STDF is a global partnership with a wellestablished, trusted presence and is uniquely qualified to further the global food safety capacity building objectives of this cooperative agreement. STDF’s mandate is to: (1) Increase awareness, mobilize resources, strengthen collaboration, identify and disseminate good practice; and (2) provide support and funding for the development and implementation of projects that promote compliance with international SPS requirements. An independent external evaluation of the STDF in 2008 concluded that the STDF ‘‘carries out an important role that no other single body would be able to accomplish.’’ (Source: STDF Newsletter, Vol. 2, Issue 1, February 2009, accessible at: www.standardsfacility.org) As such, the STDF is uniquely equipped to fulfill the objectives of this cooperative agreement due to its diverse access to WTO members in both developed and developing countries and its ability to coordinate capacity building programs at a national, VerDate Mar<15>2010 18:53 Jul 12, 2013 Jkt 229001 A. Award Amount 42085 registration/registrationInstructions.jsp. After you have followed these steps, submit electronic applications to: https://www.grants.gov. Dated: July 10, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–16860 Filed 7–12–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The Center for Food Safety and Applied Nutrition intends to fund one award up to $750,000 total costs (direct plus indirect costs) for FY 2013. Future year amounts will depend on annual appropriations and successful performance. [Docket No. FDA–2013–D–0814] B. Length of Support AGENCY: The award will provide 1 year of support and include future recommended support for 4 additional years, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations. III. Electronic Application, Registration, and Submission Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at www.fda.gov/ food/newsevents/default.htm. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) For all electronically submitted applications, the following steps are required. • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With System for Award Management (SAM) • Step 3: Obtain Username & Password • Step 4: Authorized Organization Representative (AOR) Authorization • Step 5: Track AOR Status • Step 6: Register With Electronic Research Administration (eRA) Commons Steps 1 through 5, in detail, can be found at https:// www07.grants.gov/applicants/ organization_registration.jsp. Step 6, in detail, can be found at https:// commons.era.nih.gov/commons/ PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans; Availability Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.’’ This draft guidance is intended to provide information to industry on how to submit initial and amended pediatric study plans (PSPs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 13, 2013. ADDRESSES: 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, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002, or Office of Communication, Outreach, and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section SUMMARY: E:\FR\FM\15JYN1.SGM 15JYN1 42086 Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Notices for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Rosemary Addy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993–0002, 301– 796–1640; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301– 827–6210. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.’’ The purpose of this draft guidance is to assist sponsors in the submission of an initial PSP and any amendments to the PSP. Specifically, this guidance addresses FDA’s current thinking regarding implementation of the requirement for sponsors to submit an initial PSP under section 505B of the FD&C Act as amended by FDASIA (Pub. L. 112–144, 126 Stat. 993 (enacted July 9, 2012)). This draft guidance addresses topics related to the submission of an initial PSP and any amendments to the PSP, including who must submit an initial PSP, when a PSP must be submitted, what is expected to be included in an initial PSP, and what is expected to be included in a requested amendment to an initial PSP. The guidance also includes a template that should be used for submission of an initial PSP. This draft guidance does not contain a discussion of general requirements for pediatric drug development under the Pediatric Research Equity Act. That topic is addressed in the draft guidance for industry entitled ‘‘How to Comply With the Pediatric Research Equity Act.’’ 1 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). 1 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA Drugs guidance Web page at https://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/default.htm. VerDate Mar<15>2010 18:53 Jul 12, 2013 Jkt 229001 The draft guidance, when finalized, will represent the Agency’s current thinking on the content of and process for submitting initial PSPs and amended PSPs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). The collections of information referenced in this draft guidance that are related to the burden on the submission of investigational new drug applications are covered under 21 CFR Part 312, including plans for pediatric studies under 21 CFR 312.47(b)(1)(iv) and waiver requests under 21 CFR 312.10, and have been approved under OMB control number 0910–0014. The collections of information referenced in this draft guidance that are related to the burden on the submission of new drug applications are covered under 21 CFR Part 314, including pediatric use information under 21 CFR 314.50(d)(7) and waiver requests under 21 CFR 314.90, and have been approved under OMB control number 0910–0001. The collections of information referenced in this draft guidance that are related to the burden on the submission of biologic license applications are covered under 21 CFR Part 601, including pediatric use information and waiver requests under 21 CFR 601.27, and have been approved under OMB control number 0910–0338. Sponsors are already required to submit plans for pediatric studies and often provide the information outlined in this guidance pursuant to the regulations noted above. The new FDASIA provisions primarily serve to establish a more precise timeline for the submission of that information; however, some of the information may be considered a new collection of information. Federal law at 44 U.S.C. 3506(c)(2)(A) requires Federal Agencies to publish a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA will publish a 60-day notice of the proposed collection of information in a future issue of the Federal Register for any information collections recommended in this PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 guidance that may be considered new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidances. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: July 9, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–16825 Filed 7–12–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0322] Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Arsenic in Apple Juice: Action Level’’ and two supporting documents entitled ‘‘Supporting Document for Action Level for Arsenic in Apple Juice’’ (the draft supporting document) and ‘‘A Quantitative Assessment of Inorganic Arsenic in Apple Juice’’ (the risk assessment document). The supporting documents are referenced in the draft guidance. The SUMMARY: E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42085-42086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0814]


Draft Guidance for Industry on Pediatric Study Plans: Content of 
and Process for Submitting Initial Pediatric Study Plans and Amended 
Pediatric Study Plans; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Pediatric 
Study Plans: Content of and Process for Submitting Initial Pediatric 
Study Plans and Amended Pediatric Study Plans.'' This draft guidance is 
intended to provide information to industry on how to submit initial 
and amended pediatric study plans (PSPs) as required under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug 
Administration Safety and Innovation Act (FDASIA).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 13, 2013.

ADDRESSES: 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or 
Office of Communication, Outreach, and Development (HFM-40), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section

[[Page 42086]]

for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rosemary Addy, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-1640; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Pediatric Study Plans: Content of and Process for Submitting 
Initial Pediatric Study Plans and Amended Pediatric Study Plans.'' The 
purpose of this draft guidance is to assist sponsors in the submission 
of an initial PSP and any amendments to the PSP. Specifically, this 
guidance addresses FDA's current thinking regarding implementation of 
the requirement for sponsors to submit an initial PSP under section 
505B of the FD&C Act as amended by FDASIA (Pub. L. 112-144, 126 Stat. 
993 (enacted July 9, 2012)).
    This draft guidance addresses topics related to the submission of 
an initial PSP and any amendments to the PSP, including who must submit 
an initial PSP, when a PSP must be submitted, what is expected to be 
included in an initial PSP, and what is expected to be included in a 
requested amendment to an initial PSP. The guidance also includes a 
template that should be used for submission of an initial PSP.
    This draft guidance does not contain a discussion of general 
requirements for pediatric drug development under the Pediatric 
Research Equity Act. That topic is addressed in the draft guidance for 
industry entitled ``How to Comply With the Pediatric Research Equity 
Act.'' \1\
---------------------------------------------------------------------------

    \1\ When final, this guidance will represent the FDA's current 
thinking on this topic. For the most recent version of a guidance, 
check the FDA Drugs guidance Web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
---------------------------------------------------------------------------

    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 Agency's current thinking on the content 
of and process for submitting initial PSPs and amended PSPs. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collections of information referenced in this draft guidance that 
are related to the burden on the submission of investigational new drug 
applications are covered under 21 CFR Part 312, including plans for 
pediatric studies under 21 CFR 312.47(b)(1)(iv) and waiver requests 
under 21 CFR 312.10, and have been approved under OMB control number 
0910-0014. The collections of information referenced in this draft 
guidance that are related to the burden on the submission of new drug 
applications are covered under 21 CFR Part 314, including pediatric use 
information under 21 CFR 314.50(d)(7) and waiver requests under 21 CFR 
314.90, and have been approved under OMB control number 0910-0001. The 
collections of information referenced in this draft guidance that are 
related to the burden on the submission of biologic license 
applications are covered under 21 CFR Part 601, including pediatric use 
information and waiver requests under 21 CFR 601.27, and have been 
approved under OMB control number 0910-0338.
    Sponsors are already required to submit plans for pediatric studies 
and often provide the information outlined in this guidance pursuant to 
the regulations noted above. The new FDASIA provisions primarily serve 
to establish a more precise timeline for the submission of that 
information; however, some of the information may be considered a new 
collection of information. Federal law at 44 U.S.C. 3506(c)(2)(A) 
requires Federal Agencies to publish a 60-day notice in the Federal 
Register for each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA will publish a 60-day notice of the proposed collection of 
information in a future issue of the Federal Register for any 
information collections recommended in this guidance that may be 
considered new or that would represent material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: July 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16825 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P
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