81 FR 12508 - Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 46 (March 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12508-12509 | |
| FR Document | 2016-05223 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12508-12509] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05223] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0814] Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.'' This draft guidance is intended to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP) and any amendments to the iPSP as required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This guidance revises the draft guidance entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans'' issued July 15, 2013. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 9, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2013-D-0814 for ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. [[Page 12509]] 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: Rosemary Addy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6430, Silver Spring, MD 20993-0002, 301- 796-1640; 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 Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.'' The purpose of this draft guidance is to assist sponsors in the submission of an iPSP and any amendments to an iPSP. Specifically, this guidance addresses FDA's current thinking regarding the requirement for sponsors to submit an iPSP under section 505B of the FD&C Act (21 U.S.C. 355c) as amended by FDASIA. This guidance revises the draft guidance entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans'' issued July 15, 2013 (78 FR 42085). Changes made in this draft guidance were based largely on public comments received by FDA on the 2013 draft guidance. The following topics are addressed in this draft guidance: (1) Who must submit an iPSP; (2) when an iPSP must be submitted; (3) what should be included in an iPSP; (4) what should be included in a requested amendment to an iPSP; (5) the relationship of an agreed iPSP to the requirement to submit a pediatric study plan with a marketing application; (6) what is meant by a non-agreed iPSP; and (7) processes for reaching agreement with FDA on a non-agreed iPSP. This draft guidance also includes a revised template that should be used for submission of an iPSP. 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 the content of and process for submitting iPSPs and amended iPSPs. 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. 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 (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 biologics 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. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Dated: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05223 Filed 3-8-16; 8:45 am] BILLING CODE 4164-01-P
![12508 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
describing the concept of interest and and Amended Pediatric Study Plans’’ Availability.’’ Received comments will
COU for which the tool is qualified. issued July 15, 2013. be placed in the docket and, except for
This draft guidance describes the DATES: Although you can comment on those submitted as ‘‘Confidential
qualification statement for the E–RS: any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
COPD, a COA DDT. 10.115(g)(5)), to ensure that the Agency http://www.regulations.gov or at the
This draft guidance is being issued considers your comment on this draft Division of Dockets Management
consistent with FDA’s good guidance guidance before it begins work on the between 9 a.m. and 4 p.m., Monday
practices regulation (21 CFR 10.115). final version of the guidance, submit through Friday.
The draft guidance, when finalized, will either electronic or written comments • Confidential Submissions—To
represent the current thinking of FDA on the draft guidance by May 9, 2016. submit a comment with confidential
on the qualification for exploratory use information that you do not wish to be
ADDRESSES: You may submit comments
of the E–RS: COPD. It does not establish made publicly available, submit your
as follows: comments only as a written/paper
any rights for any person and is not
binding on FDA or the public. You can Electronic Submissions submission. You should submit two
use an alternative approach if it satisfies copies total. One copy will include the
Submit electronic comments in the
the requirements of the applicable information you claim to be confidential
following way:
statutes and regulations. with a heading or cover note that states
• Federal eRulemaking Portal: http://
‘‘THIS DOCUMENT CONTAINS
II. Electronic Access www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments. Agency will review this copy, including
Persons with access to the Internet Comments submitted electronically,
may obtain the draft guidance at either the claimed confidential information, in
including attachments, to http:// its consideration of comments. The
http://www.fda.gov/Drugs/Guidance www.regulations.gov will be posted to
ComplianceRegulatoryInformation/ second copy, which will have the
the docket unchanged. Because your claimed confidential information
Guidances/default.htm or http:// comment will be made public, you are
www.regulations.gov. redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on http://
Dated: March 2, 2016. comment does not include any www.regulations.gov. Submit both
Leslie Kux, confidential information that you or a copies to the Division of Dockets
Associate Commissioner for Policy. third party may not wish to be posted, Management. If you do not wish your
[FR Doc. 2016–05224 Filed 3–8–16; 8:45 am] such as medical information, your or name and contact information to be
BILLING CODE 4164–01–P
anyone else’s Social Security number, or made publicly available, you can
confidential business information, such provide this information on the cover
as a manufacturing process. Please note sheet and not in the body of your
DEPARTMENT OF HEALTH AND that if you include your name, contact comments and you must identify this
HUMAN SERVICES information, or other information that information as ‘‘confidential.’’ Any
identifies you in the body of your information marked as ‘‘confidential’’
Food and Drug Administration comments, that information will be will not be disclosed except in
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
[Docket No. FDA–2013–D–0814]
• If you want to submit a comment applicable disclosure law. For more
Pediatric Study Plans: Content of and with confidential information that you information about FDA’s posting of
Process for Submitting Initial Pediatric do not wish to be made available to the comments to public dockets, see 80 FR
Study Plans and Amended Initial public, submit the comment as a 56469, September 18, 2015, or access
Pediatric Study Plans; Draft Guidance written/paper submission and in the the information at: http://www.fda.gov/
for Industry; Availability manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Submissions’’ and ‘‘Instructions’’). default.htm.
AGENCY: Food and Drug Administration, Docket: For access to the docket to
Written/Paper Submissions
HHS. read background documents or the
ACTION: Notice of availability. Submit written/paper submissions as electronic and written/paper comments
follows: received, go to http://
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Administration (FDA or Agency) is written/paper submissions): Division of docket number, found in brackets in the
announcing the availability of a draft Dockets Management (HFA–305), Food heading of this document, into the
guidance for industry entitled ‘‘Pediatric and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Study Plans: Content of and Process for Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
Submitting Initial Pediatric Study Plans • For written/paper comments Management, 5630 Fishers Lane, Rm.
and Amended Initial Pediatric Study submitted to the Division of Dockets 1061, Rockville, MD 20852.
Plans.’’ This draft guidance is intended Management, FDA will post your Submit written requests for single
to provide information to sponsors comment, as well as any attachments, copies of the draft guidance to the
regarding the submission of an initial except for information submitted, Division of Drug Information, Center for
pediatric study plan (iPSP) and any marked and identified, as confidential, Drug Evaluation and Research, Food
amendments to the iPSP as required if submitted as detailed in and Drug Administration, 10001 New
under the Federal Food, Drug, and ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
Lhorne on DSK5TPTVN1PROD with NOTICES
Cosmetic Act (the FD&C Act) as Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
amended by the Food and Drug must include the Docket No. FDA– 0002, or Office of Communication,
Administration Safety and Innovation 2013–D–0814 for ‘‘Pediatric Study Outreach, and Development, Center for
Act (FDASIA). This guidance revises the Plans: Content of and Process for Biologics Evaluation and Research,
draft guidance entitled ‘‘Pediatric Study Submitting Initial Pediatric Study Plans Food and Drug Administration, 10903
Plans: Content of and Process for and Amended Initial Pediatric Study New Hampshire Ave., Bldg. 71, Rm.
Submitting Initial Pediatric Study Plans Plans; Draft Guidance for Industry; 3128, Silver Spring, MD 20993–0002.
VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/81_FR_12554/page/1.svg)
![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12509
Send one self-addressed adhesive label person and is not binding on FDA or the DEPARTMENT OF HEALTH AND
to assist that office in processing your public. You can use an alternative HUMAN SERVICES
requests. See the SUPPLEMENTARY approach if it satisfies the requirements
INFORMATION section for electronic of the applicable statutes and Food and Drug Administration
access to the draft guidance document. regulations. [Docket No. FDA–2009–N–0511]
FOR FURTHER INFORMATION CONTACT:
Rosemary Addy, Center for Drug II. The Paperwork Reduction Act of Agency Information Collection
Evaluation and Research, Food and 1995 Activities; Proposed Collection;
Drug Administration, 10903 New This draft guidance includes Comment Request; Medicated Feed
Hampshire Ave., Bldg. 22, Rm. 6430, Mill License Application
information collection provisions that
Silver Spring, MD 20993–0002, 301– are subject to review by the Office of AGENCY: Food and Drug Administration,
796–1640; or Stephen Ripley, Center for Management and Budget (OMB) under HHS.
Biologics Evaluation and Research,
the Paperwork Reduction Act of 1995 ACTION: Notice.
Food and Drug Administration, 10903
(44 U.S.C. 3501–3520). The collections
New Hampshire Ave., Bldg. 71, Rm. SUMMARY: The Food and Drug
7301, Silver Spring, MD 20993–0002, of information referenced in this draft
Administration (FDA, we) is
240–402–7911. guidance that are related to the burden
announcing an opportunity for public
on the submission of investigational
SUPPLEMENTARY INFORMATION: comment on the proposed collection of
new drug applications are covered
certain information by the Agency.
I. Background under 21 CFR part 312, including plans Under the Paperwork Reduction Act of
FDA is announcing the availability of for pediatric studies under 21 CFR 1995 (the PRA), Federal Agencies are
a draft guidance for industry entitled 312.47(b)(1)(iv) and waiver requests required to publish notice in the
‘‘Pediatric Study Plans: Content of and under 21 CFR 312.10, and have been Federal Register concerning each
Process for Submitting Initial Pediatric approved under OMB control number proposed collection of information,
Study Plans and Amended Initial 0910–0014. The collections of including each proposed extension of an
Pediatric Study Plans.’’ The purpose of information referenced in this draft existing collection of information, and
this draft guidance is to assist sponsors guidance that are related to the burden to allow 60 days for public comment in
in the submission of an iPSP and any on the submission of new drug response to the notice. This notice
amendments to an iPSP. Specifically, applications are covered under 21 CFR solicits comments on the collection of
this guidance addresses FDA’s current part 314, including pediatric use information associated with Medicated
thinking regarding the requirement for information under 21 CFR 314.50(d)(7) Feed Mill License Applications.
sponsors to submit an iPSP under and waiver requests under 21 CFR DATES: Submit either electronic or
section 505B of the FD&C Act (21 U.S.C. 314.90, and have been approved under written comments on the collection of
355c) as amended by FDASIA. OMB control number 0910–0001. The information by May 9, 2016.
This guidance revises the draft collections of information referenced in ADDRESSES: You may submit comments
guidance entitled ‘‘Pediatric Study this draft guidance that are related to the as follows:
Plans: Content of and Process for burden on the submission of biologics
Submitting Initial Pediatric Study Plans Electronic Submissions
license applications are covered under
and Amended Pediatric Study Plans’’ 21 CFR part 601, including pediatric use Submit electronic comments in the
issued July 15, 2013 (78 FR 42085). following way:
information and waiver requests under
Changes made in this draft guidance
21 CFR 601.27, and have been approved • Federal eRulemaking Portal: http://
were based largely on public comments www.regulations.gov. Follow the
under OMB control number 0910–0338.
received by FDA on the 2013 draft instructions for submitting comments.
guidance. III. Electronic Access Comments submitted electronically,
The following topics are addressed in including attachments, to http://
this draft guidance: (1) Who must Persons with access to the Internet www.regulations.gov will be posted to
submit an iPSP; (2) when an iPSP must may obtain the draft guidance at http:// the docket unchanged. Because your
be submitted; (3) what should be www.fda.gov/Drugs/Guidance comment will be made public, you are
included in an iPSP; (4) what should be ComplianceRegulatoryInformation/ solely responsible for ensuring that your
included in a requested amendment to Guidances/default.htm, http:// comment does not include any
an iPSP; (5) the relationship of an www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a
agreed iPSP to the requirement to GuidanceComplianceRegulatory third party may not wish to be posted,
submit a pediatric study plan with a Information/default.htm, or http:// such as medical information, your or
marketing application; (6) what is meant www.regulations.gov. anyone else’s Social Security number, or
by a non-agreed iPSP; and (7) processes confidential business information, such
Dated: March 2, 2016.
for reaching agreement with FDA on a as a manufacturing process. Please note
non-agreed iPSP. This draft guidance Leslie Kux, that if you include your name, contact
also includes a revised template that Associate Commissioner for Policy. information, or other information that
should be used for submission of an [FR Doc. 2016–05223 Filed 3–8–16; 8:45 am] identifies you in the body of your
iPSP. BILLING CODE 4164–01–P comments, that information will be
This draft guidance is being issued posted on http://www.regulations.gov.
Lhorne on DSK5TPTVN1PROD with NOTICES
consistent with FDA’s good guidance • If you want to submit a comment
practices regulation (21 CFR 10.115). with confidential information that you
The draft guidance, when finalized, will do not wish to be made available to the
represent the current thinking of FDA public, submit the comment as a
on the content of and process for written/paper submission and in the
submitting iPSPs and amended iPSPs. It manner detailed (see ‘‘Written/Paper
does not establish any rights for any Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/81_FR_12554/page/2.svg)
Document Created: 2016-03-09 00:13:11
Document Modified: 2016-03-09 00:13:11
| 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 | 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 May 9, 2016. | |
| Contact | Rosemary Addy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6430, Silver Spring, MD 20993-0002, 301- 796-1640; 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 | 81 FR 12508 |
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