Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; Guidance for Industry; Availability, 42307-42308 [2018-17961]

Download as PDF Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices Considerations for Chewable Tablets.’’ 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. 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 collection of information in investigational new drug applications is approved by OMB under control number 0910–0014; the collection of information (including prescription drug labeling) in new drug applications and abbreviated new drug applications, as well as supplements to these applications, is approved by OMB under control number 0910–0001; the collection of biologics license applications is approved by OMB under control number 0910–0338; and the format and content of prescription drug labeling is approved by OMB under control number 0910–0572. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: August 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–17967 Filed 8–20–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2017–D–5297] Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; Guidance for Industry; Availability Food and Drug Administration, HHS. sradovich on DSK3GMQ082PROD with NOTICES ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.’’ This guidance is intended to assist sponsors of microdose SUMMARY: VerDate Sep<11>2014 19:37 Aug 20, 2018 Jkt 244001 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 Food and Drug Administration AGENCY: radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. This guidance finalizes the draft guidance of the same name issued on September 13, 2017. DATES: The announcement of the guidance is published in the Federal Register on August 21, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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; Guidance for Industry; Availability.’’ PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 42307 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/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 this 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 E:\FR\FM\21AUN1.SGM 21AUN1 42308 Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices III. Electronic Access INFORMATION section for electronic access to the guidance document. Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. 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. Dated: August 15, 2018. Leslie Kux, Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: [FR Doc. 2018–17961 Filed 8–20–18; 8:45 am] I. Background BILLING CODE 4164–01–P FDA is announcing the availability of a guidance for industry entitled ‘‘Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.’’ This guidance is intended to assist sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. This guidance incorporates comments received and finalizes the draft guidance of the same name issued on September 13, 2017 (82 FR 43025). The guidance includes a few editorial changes and a new sentence clarifying the definition of the term diagnostic radiopharmaceutical. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on nonclinical study recommendations 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. sradovich on DSK3GMQ082PROD with NOTICES II. 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. VerDate Sep<11>2014 19:37 Aug 20, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Maternal, Infant, and Early Childhood Home Visiting Program Statewide Needs Assessment Update Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted a Supplemental Information Request (SIR) to the Office of Management and Budget (OMB) for review and approval. A 60-day Federal Register Notice was published in the Federal Register on April 24, 2018. There were seven public comments. Comments submitted during the first public review of this SIR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this SIR should be received no later than September 20, 2018. SUMMARY: Submit your comments, including the Information Collection Request (ICR) Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program ADDRESSES: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Statewide Needs Assessment Update, OMB No. 0906–XXX, New. Abstract: HRSA is requesting approval to collect updated statewide needs assessments from Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program awardees. The previous statewide needs assessment that was approved under OMB control number 0915–0333 has been discontinued. Eligible entities that are states, the District of Columbia, and non-profit organizations will submit statewide needs assessment updates in response to a forthcoming SIR. The MIECHV Program, authorized by section 511 of the Social Security Act, 42 U.S.C. 711, and administered by HRSA in partnership with the Administration for Children and Families, supports voluntary, evidence-based home visiting services during pregnancy and to parents with young children up to kindergarten entry. States, territories, tribal entities, and in certain circumstances nonprofit organizations are eligible to receive funding through MIECHV and have the flexibility, within the parameters of the authorizing statute, to tailor the program to serve the specific needs of their communities. The statewide needs assessment is a critical and foundational resource that assists awardees in identifying and understanding how to meet the needs of eligible families living in at-risk communities in their states. After taking into consideration public comments in response to the 60-day Notice published in the Federal Register on April 24, 2018 (83 FR 17826), HRSA is proposing final revisions to the SIR guidance for the needs assessment update by making the following changes: • Inserting references to the statutory requirements for each section of the guidance—specifically the sections of statute that require an assessment of state capacity to provide substance abuse treatment and counseling services. • Increasing the burden estimate for respondents from 95.57 to 120 in response to comments that the original estimate was too low. Need and Proposed Use of the Information: Congress, through enactment of the Social Security Act, Title V, Section 511 (42 U.S.C. 711), as amended, established the MIECHV Program. Section 50603 of the Bipartisan Budget Act of 2018 (Pub. L. 115–123) amended section 511(b)(1) of the Social Security Act, and requires that states review and update their statewide needs assessments (which may be separate from, but in coordination with, the Title V statewide E:\FR\FM\21AUN1.SGM 21AUN1

Agencies

[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)]
[Notices]
[Pages 42307-42308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17961]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5297]


Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study 
Recommendations; 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 final guidance for industry entitled ``Microdose 
Radiopharmaceutical Diagnostic Drugs: Nonclinical Study 
Recommendations.'' This guidance is intended to assist sponsors of 
microdose radiopharmaceutical diagnostic drugs on the nonclinical 
studies recommended to support human clinical trials and marketing 
applications. This guidance finalizes the draft guidance of the same 
name issued on September 13, 2017.

DATES: The announcement of the guidance is published in the Federal 
Register on August 21, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2017-D-5297 for ``Microdose Radiopharmaceutical Diagnostic Drugs: 
Nonclinical Study Recommendations; 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 this 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

[[Page 42308]]

INFORMATION section for electronic access to the 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 guidance for industry 
entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical 
Study Recommendations.'' This guidance is intended to assist sponsors 
of microdose radiopharmaceutical diagnostic drugs on the nonclinical 
studies recommended to support human clinical trials and marketing 
applications. This guidance incorporates comments received and 
finalizes the draft guidance of the same name issued on September 13, 
2017 (82 FR 43025). The guidance includes a few editorial changes and a 
new sentence clarifying the definition of the term diagnostic 
radiopharmaceutical.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on nonclinical study recommendations 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. 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.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: August 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17961 Filed 8-20-18; 8:45 am]
BILLING CODE 4164-01-P
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