83 FR 42307 - Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 162 (August 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 162 (August 21, 2018)
| Page Range | 42307-42308 | |
| FR Document | 2018-17961 |
[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)] [Notices] [Pages 42307-42308] From the Federal Register Online [www.thefederalregister.org] [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 This guidance finalizes the draft guidance of the same name issued on September 13, 2017.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.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 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
![Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 42307
Considerations for Chewable Tablets.’’ It radiopharmaceutical diagnostic drugs Received comments will be placed in
does not establish any rights for any on the nonclinical studies the docket and, except for those
person and is not binding on FDA or the recommended to support human submitted as ‘‘Confidential
public. You can use an alternative clinical trials and marketing Submissions,’’ publicly viewable at
approach if it satisfies the requirements applications. This guidance finalizes the https://www.regulations.gov or at the
of the applicable statutes and draft guidance of the same name issued Dockets Management Staff between 9
regulations. This guidance is not subject on September 13, 2017. a.m. and 4 p.m., Monday through
to Executive Order 12866. DATES: The announcement of the Friday.
II. Paperwork Reduction Act of 1995 guidance is published in the Federal • Confidential Submissions—To
Register on August 21, 2018. submit a comment with confidential
This guidance refers to previously information that you do not wish to be
approved collections of information that ADDRESSES: You may submit either
electronic or written comments on made publicly available, submit your
are subject to review by the Office of comments only as a written/paper
Management and Budget (OMB) under Agency guidances at any time as
follows: submission. You should submit two
the Paperwork Reduction Act of 1995 copies total. One copy will include the
(44 U.S.C. 3501–3520). The collection of Electronic Submissions information you claim to be confidential
information in investigational new drug with a heading or cover note that states
applications is approved by OMB under Submit electronic comments in the
following way: ‘‘THIS DOCUMENT CONTAINS
control number 0910–0014; the CONFIDENTIAL INFORMATION.’’ The
collection of information (including • Federal eRulemaking Portal:
https://www.regulations.gov. Follow the Agency will review this copy, including
prescription drug labeling) in new drug the claimed confidential information, in
applications and abbreviated new drug instructions for submitting comments.
Comments submitted electronically, its consideration of comments. The
applications, as well as supplements to second copy, which will have the
these applications, is approved by OMB including attachments, to https://
www.regulations.gov will be posted to claimed confidential information
under control number 0910–0001; the redacted/blacked out, will be available
collection of biologics license the docket unchanged. Because your
comment will be made public, you are for public viewing and posted on
applications is approved by OMB under https://www.regulations.gov. Submit
control number 0910–0338; and the solely responsible for ensuring that your
comment does not include any both copies to the Dockets Management
format and content of prescription drug Staff. If you do not wish your name and
labeling is approved by OMB under confidential information that you or a
third party may not wish to be posted, contact information to be made publicly
control number 0910–0572. available, you can provide this
such as medical information, your or
III. Electronic Access anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Persons with access to the internet
as a manufacturing process. Please note must identify this information as
may obtain the guidance at either
that if you include your name, contact ‘‘confidential.’’ Any information marked
https://www.fda.gov/Drugs/Guidance
information, or other information that as ‘‘confidential’’ will not be disclosed
ComplianceRegulatoryInformation/
identifies you in the body of your except in accordance with 21 CFR 10.20
Guidances/default.htm or https://
comments, that information will be and other applicable disclosure law. For
www.regulations.gov.
posted on https://www.regulations.gov. more information about FDA’s posting
Dated: August 15, 2018. of comments to public dockets, see 80
• If you want to submit a comment
Leslie Kux, FR 56469, September 18, 2015, or access
with confidential information that you
Associate Commissioner for Policy. do not wish to be made available to the the information at: https://www.gpo.gov/
[FR Doc. 2018–17967 Filed 8–20–18; 8:45 am] public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
BILLING CODE 4164–01–P written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
DEPARTMENT OF HEALTH AND electronic and written/paper comments
HUMAN SERVICES Written/Paper Submissions received, go to https://
Submit written/paper submissions as www.regulations.gov and insert the
Food and Drug Administration docket number, found in brackets in the
follows:
[Docket No. FDA–2017–D–5297] • Mail/Hand delivery/Courier (for heading of this document, into the
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Microdose Radiopharmaceutical Management Staff (HFA–305), Food and and/or go to the Dockets Management
Diagnostic Drugs: Nonclinical Study Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Recommendations; Guidance for Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
Industry; Availability • For written/paper comments You may submit comments on any
AGENCY: Food and Drug Administration, submitted to the Dockets Management guidance at any time (see 21 CFR
HHS. Staff, FDA will post your comment, as 10.115(g)(5)).
ACTION: Notice of availability. well as any attachments, except for Submit written requests for single
information submitted, marked and copies of this guidance to the Division
SUMMARY: The Food and Drug identified, as confidential, if submitted of Drug Information, Center for Drug
sradovich on DSK3GMQ082PROD with NOTICES
Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’ Evaluation and Research, Food and
announcing the availability of a final Instructions: All submissions received Drug Administration, 10001 New
guidance for industry entitled must include the Docket No. FDA– Hampshire Ave., Hillandale Building,
‘‘Microdose Radiopharmaceutical 2017–D–5297 for ‘‘Microdose 4th Floor, Silver Spring, MD 20993–
Diagnostic Drugs: Nonclinical Study Radiopharmaceutical Diagnostic Drugs: 0002. Send one self-addressed adhesive
Recommendations.’’ This guidance is Nonclinical Study Recommendations; label to assist that office in processing
intended to assist sponsors of microdose Guidance for Industry; Availability.’’ your requests. See the SUPPLEMENTARY
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![42308 Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices
INFORMATION section for electronic III. Electronic Access Statewide Needs Assessment Update,
access to the guidance document. Persons with access to the internet OMB No. 0906–XXX, New.
Abstract: HRSA is requesting
FOR FURTHER INFORMATION CONTACT: may obtain the guidance at either
approval to collect updated statewide
Adebayo Laniyonu, Center for Drug https://www.fda.gov/Drugs/Guidance
needs assessments from Maternal,
Evaluation and Research, Food and ComplianceRegulatoryInformation/
Infant, and Early Childhood Home
Drug Administration, 10903 New Guidances/default.htm or https://
Visiting (MIECHV) Program awardees.
Hampshire Ave., Bldg. 22, Rm. 5400, www.regulations.gov. The previous statewide needs
Silver Spring, MD 20993–0002, 301– Dated: August 15, 2018. assessment that was approved under
796–1392. Leslie Kux, OMB control number 0915–0333 has
SUPPLEMENTARY INFORMATION: Associate Commissioner for Policy. been discontinued. Eligible entities that
[FR Doc. 2018–17961 Filed 8–20–18; 8:45 am] are states, the District of Columbia, and
I. Background BILLING CODE 4164–01–P
non-profit organizations will submit
statewide needs assessment updates in
FDA is announcing the availability of response to a forthcoming SIR. The
a guidance for industry entitled MIECHV Program, authorized by section
DEPARTMENT OF HEALTH AND
‘‘Microdose Radiopharmaceutical 511 of the Social Security Act, 42 U.S.C.
HUMAN SERVICES
Diagnostic Drugs: Nonclinical Study 711, and administered by HRSA in
Recommendations.’’ This guidance is Health Resources and Services partnership with the Administration for
intended to assist sponsors of microdose Administration Children and Families, supports
radiopharmaceutical diagnostic drugs voluntary, evidence-based home visiting
on the nonclinical studies Agency Information Collection services during pregnancy and to
recommended to support human Activities: Submission to OMB for parents with young children up to
clinical trials and marketing Review and Approval; Public Comment kindergarten entry. States, territories,
applications. This guidance Request; The Maternal, Infant, and tribal entities, and in certain
incorporates comments received and Early Childhood Home Visiting circumstances nonprofit organizations
finalizes the draft guidance of the same Program Statewide Needs Assessment are eligible to receive funding through
name issued on September 13, 2017 (82 Update MIECHV and have the flexibility, within
FR 43025). The guidance includes a few the parameters of the authorizing
editorial changes and a new sentence AGENCY: Health Resources and Services
statute, to tailor the program to serve the
clarifying the definition of the term Administration (HRSA), Department of
specific needs of their communities.
diagnostic radiopharmaceutical. Health and Human Services. The statewide needs assessment is a
ACTION: Notice. critical and foundational resource that
This guidance is being issued
consistent with FDA’s good guidance assists awardees in identifying and
SUMMARY: In compliance with of the understanding how to meet the needs of
practices regulation (21 CFR 10.115). Paperwork Reduction Act of 1995,
The guidance represents the current eligible families living in at-risk
HRSA has submitted a Supplemental communities in their states.
thinking of FDA on nonclinical study Information Request (SIR) to the Office After taking into consideration public
recommendations for microdose of Management and Budget (OMB) for comments in response to the 60-day
radiopharmaceutical diagnostic drugs. It review and approval. A 60-day Federal Notice published in the Federal
does not establish any rights for any Register Notice was published in the Register on April 24, 2018 (83 FR
person and is not binding on FDA or the Federal Register on April 24, 2018. 17826), HRSA is proposing final
public. You can use an alternative There were seven public comments. revisions to the SIR guidance for the
approach if it satisfies the requirements Comments submitted during the first needs assessment update by making the
of the applicable statutes and public review of this SIR will be following changes:
regulations. This guidance is not subject provided to OMB. OMB will accept • Inserting references to the statutory
to Executive Order 12866. further comments from the public requirements for each section of the
II. Paperwork Reduction Act of 1995 during the review and approval period. guidance—specifically the sections of
DATES: Comments on this SIR should be statute that require an assessment of
This guidance refers to previously received no later than September 20, state capacity to provide substance
approved collections of information that 2018. abuse treatment and counseling
are subject to review by the Office of services.
ADDRESSES: Submit your comments,
Management and Budget (OMB) under • Increasing the burden estimate for
the Paperwork Reduction Act of 1995 including the Information Collection
respondents from 95.57 to 120 in
(44 U.S.C. 3501–3520). The collections Request (ICR) Title, to the desk officer
response to comments that the original
of information in 21 CFR parts 312 and for HRSA, either by email to OIRA_
estimate was too low.
314 have been approved under OMB submission@omb.eop.gov or by fax to Need and Proposed Use of the
control numbers 0910–0014 and 0910– 202–395–5806. Information: Congress, through
0001, respectively. The collection of FOR FURTHER INFORMATION CONTACT: To enactment of the Social Security Act,
information for radioactive drug request a copy of the clearance requests Title V, Section 511 (42 U.S.C. 711), as
research committees in 21 CFR 361.1 submitted to OMB for review, email Lisa amended, established the MIECHV
has been approved under OMB control Wright-Solomon, the HRSA Information Program. Section 50603 of the
sradovich on DSK3GMQ082PROD with NOTICES
number 0910–0053. The collection of Collection Clearance Officer at Bipartisan Budget Act of 2018 (Pub. L.
information for the regulations on in paperwork@hrsa.gov or call (301) 443– 115–123) amended section 511(b)(1) of
vivo radiopharmaceuticals used for 1984. the Social Security Act, and requires
diagnosis and monitoring in 21 CFR SUPPLEMENTARY INFORMATION: that states review and update their
315.4, 315.5, and 315.6 has been Information Collection Request Title: statewide needs assessments (which
approved under OMB control number The Maternal, Infant, and Early may be separate from, but in
0910–0409. Childhood Home Visiting Program coordination with, the Title V statewide
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Document Created: 2018-08-21 00:06:31
Document Modified: 2018-08-21 00:06:31
| 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 | The announcement of the guidance is published in the Federal Register on August 21, 2018. | |
| 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 | 83 FR 42307 |
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