82 FR 43025 - Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 176 (September 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 176 (September 13, 2017)
| Page Range | 43025-43026 | |
| FR Document | 2017-19435 |
[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)] [Notices] [Pages 43025-43026] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19435] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5297] Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.'' This draft guidance is intended to assist developers of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics. This draft guidance is intended to provide recommendations for a pathway to full drug development (marketing authorization) for microdose radiopharmaceutical diagnostic drugs. DATES: Submit either electronic or written comments on the draft guidance by November 13, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 43026]] 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-2017-D-5297 for ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; 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. 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: Adebayo Laniyonu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5400, Silver Spring, MD 20993-0002, 301- 796-1392. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.'' This draft guidance is intended to assist developers of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics. This draft guidance is intended to provide recommendations for a pathway to full drug development (marketing authorization) for microdose radiopharmaceutical diagnostic drugs. 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 nonclinical studies recommended for microdose radiopharmaceutical diagnostic drugs. 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. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information 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 in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. The collection of information for radioactive drug research committees in 21 CFR 361.1 has been approved under OMB control number 0910-0053. The collection of information for the regulations on in vivo radiopharmaceuticals used for diagnosis and monitoring in 21 CFR 315.4, 315.5, and 315.6 has been approved under OMB control number 0910-0409. 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 or https://www.regulations.gov. Dated: September 7, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-19435 Filed 9-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Notices 43025
Prevention, and the Agency for Toxic Title: Case Plan Requirement, Title to the child’s parental home, consistent
Substances and Disease Registry. IV–E of the Social Security Act. with the best interest and special needs
OMB No.: 0970–0428. of the child. Through these
Claudette Grant, Respondents: State and Tribe title IV– requirements, States and Tribes also
Acting Director, Management Analysis and B and title IV–E agencies. comply, in part, with title IV–B section
Services Office, Centers for Disease Control Description: Under section 471(a)(16) 422(b) of the Act, which assures certain
and Prevention. of title IV–E of the Social Security Act protections for children in foster care.
[FR Doc. 2017–19444 Filed 9–12–17; 8:45 am] (the Act), to be eligible for payments, The case plan is a written document
BILLING CODE 4160–18–P states and tribes must have an approved that provides a narrative description of
title IV–E plan that provides for the the child-specific program of care.
development of a case plan for each Federal regulations at 45 CFR 1356.21(g)
DEPARTMENT OF HEALTH AND child for whom the State or Tribe and section 475(1) of the Act delineate
HUMAN SERVICES receives foster care maintenance the specific information that should be
payments and that provides a case addressed in the case plan. The
Administration for Children and review system that meets the Administration for Children and
Families requirements in section 475(5) and Families (ACF) does not specify a
475(6) of the Act. recordkeeping format for the case plan
Proposed Information Collection The case review system assures that nor does ACF require submission of the
Activity; Comment Request each child has a case plan designed to document to the Federal government.
achieve placement in a safe setting that Case plan information is recorded in a
Proposed Projects: Grant Reviewer is the least restrictive (most family-like) format developed and maintained by the
Recruitment and Recordkeeping. setting available and in close proximity State or Tribal child welfare agency.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Case Plan ........................................................................................................ 544,098 1 4.80 2,626,436
Estimated Total Annual Burden comments and suggestions submitted study recommendations for this class of
Hours: 2,626,436. within 60 days of this publication. drug given its unique characteristics.
In compliance with the requirements This draft guidance is intended to
Robert Sargis,
of the Paperwork Reduction Act of 1995 provide recommendations for a pathway
(Pub. L. 104–13, 44 U.S.C. Chap 35), the Reports Clearance Officer. to full drug development (marketing
Administration for Children and [FR Doc. 2017–19367 Filed 9–12–17; 8:45 am] authorization) for microdose
Families is soliciting public comment BILLING CODE 4184–25–P radiopharmaceutical diagnostic drugs.
on the specific aspects of the DATES: Submit either electronic or
information collection described above. written comments on the draft guidance
Copies of the proposed collection of DEPARTMENT OF HEALTH AND
by November 13, 2017 to ensure that the
information may be obtained and HUMAN SERVICES
Agency considers your comment on this
comments may be forwarded by writing Food and Drug Administration draft guidance before it begins work on
to the Administration for Children and the final version of the guidance.
Families, Office of Planning, Research [Docket No. FDA–2017–D–5297] ADDRESSES: You may submit comments
and Evaluation, 330 C Street SW., on any guidance at any time as follows:
Washington, DC 20201. Attn: ACF Microdose Radiopharmaceutical
Reports Clearance Officer. Email Diagnostic Drugs: Nonclinical Study Electronic Submissions
address: infocollection@acf.hhs.gov. All Recommendations; Draft Guidance for Submit electronic comments in the
requests should be identified by the title Industry; Availability following way:
of the information collection. AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
The Department specifically requests HHS. https://www.regulations.gov. Follow the
comments on: (a) Whether the proposed ACTION: Notice of availability. instructions for submitting comments.
collection of information is necessary Comments submitted electronically,
for the proper performance of the SUMMARY: The Food and Drug including attachments, to https://
functions of the agency, including Administration (FDA or Agency) is www.regulations.gov will be posted to
whether the information shall have announcing the availability of a draft the docket unchanged. Because your
practical utility; (b) the accuracy of the guidance for industry entitled comment will be made public, you are
agency’s estimate of the burden of the ‘‘Microdose Radiopharmaceutical solely responsible for ensuring that your
proposed collection of information; (c) Diagnostic Drugs: Nonclinical Study comment does not include any
the quality, utility, and clarity of the Recommendations.’’ This draft guidance confidential information that you or a
sradovich on DSK3GMQ082PROD with NOTICES
information to be collected; and (d) is intended to assist developers of third party may not wish to be posted,
ways to minimize the burden of the microdose radiopharmaceutical such as medical information, your or
collection of information on diagnostic drugs on the nonclinical anyone else’s Social Security number, or
respondents, including through the use studies recommended to support human confidential business information, such
of automated collection techniques or clinical trials and marketing as a manufacturing process. Please note
other forms of information technology. authorization. The draft guidance that if you include your name, contact
Consideration will be given to discusses how to refine nonclinical information, or other information that
VerDate Sep<11>2014 17:34 Sep 12, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1](https://thefederalregister.org/doc/82_FR_43201/page/1.svg)
![43026 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Notices
identifies you in the body of your and other applicable disclosure law. For diagnostic drugs. It does not establish
comments, that information will be more information about FDA’s posting any rights for any person and is not
posted on https://www.regulations.gov. of comments to public dockets, see 80 binding on FDA or the public. You can
• If you want to submit a comment FR 56469, September 18, 2015, or access use an alternative approach if it satisfies
with confidential information that you the information at: https://www.gpo.gov/ the requirements of the applicable
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- statutes and regulations. This guidance
public, submit the comment as a 23389.pdf. is not subject to Executive Order 12866.
written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper II. The Paperwork Reduction Act of
read background documents or the
Submissions’’ and ‘‘Instructions’’). 1995
electronic and written/paper comments
received, go to https:// This guidance refers to previously
Written/Paper Submissions
www.regulations.gov and insert the approved collections of information that
Submit written/paper submissions as docket number, found in brackets in the are subject to review by the Office of
follows: heading of this document, into the Management and Budget (OMB) under
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts the Paperwork Reduction Act of 1995
written/paper submissions): Dockets and/or go to the Dockets Management (44 U.S.C. 3501–3520). The collections
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, of information in 21 CFR parts 312 and
Drug Administration, 5630 Fishers 314 have been approved under OMB
Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any control numbers 0910–0014 and 0910–
• For written/paper comments 0001, respectively. The collection of
guidance at any time (see 21 CFR
submitted to the Dockets Management information for radioactive drug
10.115(g)(5)). Submit written requests
Staff, FDA will post your comment, as research committees in 21 CFR 361.1
well as any attachments, except for for single copies of the draft guidance to
the Division of Drug Information, Center has been approved under OMB control
information submitted, marked and number 0910–0053. The collection of
identified, as confidential, if submitted for Drug Evaluation and Research, Food
and Drug Administration, 10001 New information for the regulations on in
as detailed in ‘‘Instructions.’’ vivo radiopharmaceuticals used for
Instructions: All submissions received Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993– diagnosis and monitoring in 21 CFR
must include the Docket No. FDA–
0002. Send one self-addressed adhesive 315.4, 315.5, and 315.6 has been
2017–D–5297 for ‘‘Microdose
label to assist that office in processing approved under OMB control number
Radiopharmaceutical Diagnostic Drugs:
your requests. See the SUPPLEMENTARY 0910–0409.
Nonclinical Study Recommendations;
Draft Guidance for Industry; INFORMATION section for electronic II. Electronic Access
Availability.’’ Received comments will access to the draft guidance document.
Persons with access to the internet
be placed in the docket and, except for FOR FURTHER INFORMATION CONTACT:
may obtain the draft guidance at either
those submitted as ‘‘Confidential Adebayo Laniyonu, Center for Drug
https://www.fda.gov/Drugs/Guidance
Submissions,’’ publicly viewable at Evaluation and Research, Food and
ComplianceRegulatoryInformation/
https://www.regulations.gov or at the Drug Administration, 10903 New
Guidances/default.htm or https://
Dockets Management Staff between 9 Hampshire Ave., Bldg. 22, Rm. 5400,
www.regulations.gov.
a.m. and 4 p.m., Monday through Silver Spring, MD 20993–0002, 301–
Friday. 796–1392. Dated: September 7, 2017.
• Confidential Submissions—To SUPPLEMENTARY INFORMATION: Leslie Kux,
submit a comment with confidential Associate Commissioner for Policy.
information that you do not wish to be I. Background [FR Doc. 2017–19435 Filed 9–12–17; 8:45 am]
made publicly available, submit your FDA is announcing the availability of BILLING CODE 4164–01–P
comments only as a written/paper a draft guidance for industry entitled
submission. You should submit two ‘‘Microdose Radiopharmaceutical
copies total. One copy will include the Diagnostic Drugs: Nonclinical Study DEPARTMENT OF HEALTH AND
information you claim to be confidential Recommendations.’’ This draft guidance HUMAN SERVICES
with a heading or cover note that states is intended to assist developers of
‘‘THIS DOCUMENT CONTAINS microdose radiopharmaceutical National Institutes of Health
CONFIDENTIAL INFORMATION.’’ The diagnostic drugs on the nonclinical
Agency will review this copy, including studies recommended to support human Government-Owned Inventions;
the claimed confidential information, in clinical trials and marketing Availability for Licensing
its consideration of comments. The authorization. The draft guidance AGENCY: National Institutes of Health,
second copy, which will have the discusses how to refine nonclinical Department of Health and Human
claimed confidential information study recommendations for this class of Services.
redacted/blacked out, will be available drug given its unique characteristics. ACTION: Notice.
for public viewing and posted on This draft guidance is intended to
https://www.regulations.gov. Submit provide recommendations for a pathway SUMMARY: Government owned
both copies to the Dockets Management to full drug development (marketing intellectual property covering HIV-1
Staff. If you do not wish your name and authorization) for microdose reverse transcriptase inhibitors available
contact information to be made publicly radiopharmaceutical diagnostic drugs. for licensing and commercialization.
sradovich on DSK3GMQ082PROD with NOTICES
available, you can provide this This draft guidance is being issued FOR FURTHER INFORMATION CONTACT:
information on the cover sheet and not consistent with FDA’s good guidance Licensing information and copies of the
in the body of your comments and you practices regulation (21 CFR 10.115). patent applications listed below may be
must identify this information as The draft guidance, when finalized, will obtained by emailing the indicated
‘‘confidential.’’ Any information marked represent the current thinking of FDA licensing contact at the National Heart,
as ‘‘confidential’’ will not be disclosed on nonclinical studies recommended for Lung, and Blood, Office of Technology
except in accordance with 21 CFR 10.20 microdose radiopharmaceutical Transfer and Development Office of
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Document Created: 2017-09-13 00:08:52
Document Modified: 2017-09-13 00:08:52
| 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 November 13, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Adebayo Laniyonu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5400, Silver Spring, MD 20993-0002, 301- 796-1392. | |
| FR Citation | 82 FR 43025 |
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