82 FR 50885 - Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 211 (November 2, 2017)

Page Range		50885-50887
FR Document		2017-23836

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.

Federal Register, Volume 82 Issue 211 (Thursday, November 2, 2017)

[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Pages 50885-50887]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0998]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for 
Diagnosis and Monitoring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection in the regulations 
for in vivo radiopharmaceuticals used for diagnosis and monitoring.

DATES: Submit either electronic or written comments on the collection 
of information by January 2, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 2, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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://

[[Page 50886]]

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-2010-N-0988 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Regulations for In Vivo 
Radiopharmaceuticals Used for Diagnosis and Monitoring.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and 
Monitoring

OMB Control Number 0910-0409--Extension

    This information collection supports FDA regulations found in 21 
CFR part 315. These regulations require manufacturers of diagnostic 
radiopharmaceuticals to submit information that demonstrates the safety 
and effectiveness of a new diagnostic radiopharmaceutical or of a new 
indication for use of an approved diagnostic radiopharmaceutical. The 
regulations also describe the kinds of indications for diagnostic 
radiopharmaceuticals and some of the criteria that the Agency uses to 
evaluate the safety and effectiveness of a diagnostic 
radiopharmaceutical under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) (the FD&C Act) and section 351 of the 
Public Health Service Act (42 U.S.C. 262) (the PHS Act). Information 
about the safety or effectiveness of a diagnostic radiopharmaceutical 
enables FDA to properly evaluate the safety and effectiveness profiles 
of a new diagnostic radiopharmaceutical or a new indication for use of 
an approved diagnostic radiopharmaceutical.
    The regulations clarify existing FDA requirements for approval and 
evaluation of drug and biological products already in place under the 
authorities of the FD&C Act and the PHS Act. The information, which is 
usually submitted as part of a new drug application or biologics 
license application or as a supplement to an approved application, 
typically includes, but is not limited to, nonclinical and clinical 
data on the pharmacology, toxicology, adverse events, radiation safety 
assessments, and chemistry, manufacturing, and controls. The content 
and format of an application for approval of a new drug

[[Page 50887]]

are set forth in 21 CFR 314.50, and approved under OMB control number 
0910-0001. This information collection supports part 315, currently 
approved under OMB control number 0910-0409.
    Based on past submissions (human drug applications and/or new 
indication supplements for diagnostic radiopharmaceuticals), we 
estimate two submissions will be received annually. We estimate the 
time needed to prepare a complete application for a diagnostic 
radiopharmaceutical to be approximately 10,000 hours, roughly one-fifth 
of which, or 2,000 hours, is estimated to be spent preparing the 
portions of the application that would be affected by these 
regulations. The regulations do not impose any additional reporting 
burden for safety and effectiveness information on diagnostic 
radiopharmaceuticals beyond the estimated burden of 2,000 hours because 
safety and effectiveness information is already required by Sec.  
314.50 (collection of information approved under OMB control number 
0910-0001). In fact, clarification in these regulations of FDA's 
criteria for evaluation of diagnostic radiopharmaceuticals is intended 
to streamline overall information collection burdens, particularly for 
diagnostic radiopharmaceuticals that may have well-established, low-
risk safety profiles, by enabling manufacturers to tailor information 
submissions and avoid unnecessary clinical studies.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                            Number of                    Average
                                              Number of     responses   Total annual   burden per
              21 CFR section                 respondents       per        responses     response     Total hours
                                                           respondent                  (in hours)
----------------------------------------------------------------------------------------------------------------
Diagnostic Radiopharmaceuticals--315.4,               2             1             2         2,000         4,000
 315.5, and 315.6.........................
----------------------------------------------------------------------------------------------------------------
\1\[thinsp]There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 1 contains estimates of the annual reporting burden for the 
preparation of the safety and effectiveness sections of an application 
that are imposed by the applicable regulations. This estimate does not 
include time needed to conduct studies and clinical trials or other 
research from which the reported information is obtained.

    Dated: October 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23836 Filed 11-1-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50885

MD 20993, 301–796–0674, II. Topics for Discussion at the Dated: October 30, 2017.
OMPTfeedback@fda.hhs.gov. Assessment of FDA Hiring and Anna K. Abram,
SUPPLEMENTARY INFORMATION: Retention Public Meeting Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
I. Background The agenda will be posted prior to the [FR Doc. 2017–23899 Filed 11–1–17; 8:45 am]
FDA is responsible for protecting and meeting at: https://www.fda.gov/ BILLING CODE 4164–01–P
promoting the public health by helping NewsEvents/
to ensure the safety, efficacy, and MeetingsConferencesWorkshops/
security of human and veterinary drugs, ucm577055.htm, and will involve a DEPARTMENT OF HEALTH AND
biological products, and medical plenary presentation related to the HUMAN SERVICES
devices; and by helping to ensure the assessment findings summarized in the
safety of the nation’s food supply, ‘‘Initial Assessment of FDA’s Hiring and Food and Drug Administration
cosmetics, and products that emit Retention’’ report and an open public [Docket No. FDA–2014–N–0998]
radiation. FDA also has responsibility comment period.
for regulating the manufacturing, Registration: The FDA Conference Agency Information Collection
marketing, and distribution of tobacco Center at the White Oak location is a Activities; Proposed Collection;
products to protect the public health Federal facility with security procedures Comment Request; Regulations for In
and to reduce tobacco use by minors. and limited seating. Attendance will be Vivo Radiopharmaceuticals Used for
Included in this is a mandate to free and on a first-come, first-served Diagnosis and Monitoring
advance the public health mission by basis. If you wish to attend (either in
helping to speed innovations that make AGENCY: Food and Drug Administration,
person or by webcast) (see Streaming HHS.
medical products more effective, safer, Webcast of the Public Meeting), please
and more affordable, and helping the ACTION: Notice.
register online by 12 noon on Friday,
public access accurate science-based November 24, Eastern Time at the SUMMARY: The Food and Drug
information for FDA-regulated products. following Web site: https:// Administration (FDA or Agency) is
Just as the science and technology www.fda.gov/NewsEvents/ announcing an opportunity for public
underlying new medical products is MeetingsConferencesWorkshops/ comment on the proposed collection of
advancing, the science of development ucm577055.htm. Please provide certain information by the Agency.
and evaluation of medical products and complete contact information for each Under the Paperwork Reduction Act of
clinical care is also dramatically attendee, including name, title, 1995 (PRA), Federal Agencies are
improving. To enable FDA to continue affiliation, address, email, and required to publish notice in the
to effectively evaluate these innovative telephone. You will receive Federal Register concerning each
developments, a specialized workforce confirmation of your registration. proposed collection of information,
is required to support the Agency’s including each proposed extension of an
regulatory science and operations If you need special accommodations
due to a disability, please contact existing collection of information, and
initiatives. to allow 60 days for public comment in
Over the past 5 years, the Agency has OMPTfeedback@fda.hhs.gov no later
than Friday, November 24, at 12 noon response to the notice. This notice
struggled with challenges related to its
Eastern Time. solicits comments on information
hiring processes, including challenges
collection in the regulations for in vivo
in managing the hiring process and Streaming Webcast of the Public radiopharmaceuticals used for diagnosis
bringing the right skills to the Agency. Meeting: This public meeting will also and monitoring.
FDA has demonstrated that diagnosing be live webcast. To join the meeting via
DATES: Submit either electronic or
the current state and drastically the webcast, please go to https://
reimagining the hiring process is a top written comments on the collection of
collaboration.fda.gov/
priority and is committed to information by January 2, 2018.
fdahiringretention. If you have never
implementing new, bold, consistent, ADDRESSES: You may submit comments
attended a Connect Pro event before,
and high quality hiring processes to test your connection at https:// as follows. Please note that late,
tackle these challenges. The criticality collaboration.fda.gov/common/help/en/ untimely filed comments will not be
of these priorities is consistent with the support/meeting_test.htm. To get a considered. Electronic comments must
PDUFA VI and BsUFA II user-fee quick overview of the Connect Pro be submitted on or before January 2,
commitments. These commitments program, visit https://www.adobe.com/ 2018. The https://www.regulations.gov
include the use of a qualified, go/connectpro_overview. FDA has electronic filing system will accept
independent contractor with expertise verified the Web site addresses in this comments until midnight Eastern Time
in assessing human resources operations document, as of the date this document at the end of January 2, 2018. Comments
and transformation to perform an initial publishes in the Federal Register, but received by mail/hand delivery/courier
baseline assessment no later than Web sites are subject to change over (for written/paper submissions) will be
December 31, 2017, and a public time. considered timely if they are
meeting no later than December 31, postmarked or the delivery service
Transcripts: Please be advised that as acceptance receipt is on or before that
2017, to present and discuss report soon as a transcript of the public
findings.1 2 date.
asabaliauskas on DSKBBXCHB2PROD with NOTICES

meeting is available, it will be accessible
at https://www.regulations.gov. It may Electronic Submissions
1 PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2018 Through 2022, be viewed at the Dockets Management Submit electronic comments in the
https://www.fda.gov/downloads/forindustry/ Staff (see ADDRESSES). A link to the following way:
userfees/prescriptiondruguserfee/ucm511438.pdf. transcript will also be available on the • Federal eRulemaking Portal:
2 Biosimilar Biological Product Reauthorization
internet at https://www.fda.gov/ https://www.regulations.gov. Follow the
Performance Goals and Procedures Fiscal Years
2018 Through 2022, https://www.fda.gov/
NewsEvents/ instructions for submitting comments.
downloads/ForIndustry/UserFees/ MeetingsConferencesWorkshops/ Comments submitted electronically,
BiosimilarUserFeeActBsUFA/UCM521121.pdf. ucm577055.htm. including attachments, to https://

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Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50887

are set forth in 21 CFR 314.50, and one-fifth of which, or 2,000 hours, is these regulations of FDA’s criteria for
approved under OMB control number estimated to be spent preparing the evaluation of diagnostic
0910–0001. This information collection portions of the application that would radiopharmaceuticals is intended to
supports part 315, currently approved be affected by these regulations. The streamline overall information
under OMB control number 0910–0409. regulations do not impose any collection burdens, particularly for
Based on past submissions (human additional reporting burden for safety diagnostic radiopharmaceuticals that
drug applications and/or new indication and effectiveness information on may have well-established, low-risk
supplements for diagnostic diagnostic radiopharmaceuticals beyond safety profiles, by enabling
radiopharmaceuticals), we estimate two the estimated burden of 2,000 hours manufacturers to tailor information
submissions will be received annually. because safety and effectiveness submissions and avoid unnecessary
We estimate the time needed to prepare information is already required by
clinical studies.
a complete application for a diagnostic § 314.50 (collection of information
radiopharmaceutical to be approved under OMB control number FDA estimates the burden of this
approximately 10,000 hours, roughly 0910–0001). In fact, clarification in information collection as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual burden per
21 CFR section Total hours
respondents per responses response
respondent (in hours)

Diagnostic Radiopharmaceuticals—315.4, 315.5, and 315.6 ................. 2 1 2 2,000 4,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 1 contains estimates of the Name of Committee: National Institute of FOR FURTHER INFORMATION CONTACT:
annual reporting burden for the Nursing Research Special Emphasis Panel; Licensing information and copies of the
preparation of the safety and NINR Clinical Trial Planning Grant. patent applications listed below may be
effectiveness sections of an application Date: November 17, 2017. obtained by emailing the indicated
Time: 1:00 p.m. to 3:00 p.m.
that are imposed by the applicable Agenda: To review and evaluate grant
licensing contact Michael Shmilovich,
regulations. This estimate does not applications. shmilovm@nih.gov at the National
include time needed to conduct studies Place: National Institutes of Health, Heart, Lung, and Blood, Office of
and clinical trials or other research from National Institute of Nursing Research, One Technology Transfer and Development
which the reported information is Democracy Plaza, 6701 Democracy Office of Technology Transfer, 31 Center
obtained. Boulevard, Room 703, Bethesda, MD 20892 Drive Room 4A29, MSC2479, Bethesda,
(Telephone Conference Call). MD 20892–2479; telephone: 301–402–
Dated: October 27, 2017. Contact Person: Weiqun Li, MD, Scientific 5579. A signed Confidential Disclosure
Anna K. Abram, Review Officer, National Institute of Nursing Agreement may be required to receive
Deputy Commissioner for Policy, Planning, Research, National Institutes of Health, 6701
Legislation, and Analysis. Democracy Boulevard, Room 710, Bethesda,
copies of the patent applications.
[FR Doc. 2017–23836 Filed 11–1–17; 8:45 am] MD 20892, (301) 594–5966, SUPPLEMENTARY INFORMATION: This
BILLING CODE 4164–01–P
wli@mail.nih.gov. notice is in accordance with 35 U.S.C.
(Catalogue of Federal Domestic Assistance 209 and 37 CFR 404 to achieve
Program Nos. 93.361, Nursing Research, commercialization of results of
DEPARTMENT OF HEALTH AND National Institutes of Health, HHS) federally-funded research and
HUMAN SERVICES Dated: October 30, 2017. development. Foreign patent
Sylvia L. Neal, applications are filed on selected
National Institutes of Health Program Analyst, Office of Federal Advisory inventions to extend market coverage
Committee Policy. for companies and may also be available
National Institute of Nursing Research; for licensing. A description of the
[FR Doc. 2017–23865 Filed 11–1–17; 8:45 am]
Notice of Closed Meeting technology follows.
BILLING CODE 4140–01–P

Pursuant to section 10(d) of the Endo-Cameral Closure Device
Federal Advisory Committee Act, as Description of Technology: Devices
amended, notice is hereby given of the DEPARTMENT OF HEALTH AND
HUMAN SERVICES and methods for closing a hole in the
following meeting. wall of a cardiovascular structure from
The meeting will be closed to the National Institutes of Health the inside using a self-assembling
public in accordance with the closure device. The closure device can
provisions set forth in sections Government-Owned Inventions; be delivered to the subject hole from the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Availability for Licensing inside of the cardiovascular chamber
asabaliauskas on DSKBBXCHB2PROD with NOTICES

as amended. The grant applications and using a transcatheter approach. The
the discussions could disclose AGENCY: National Institutes of Health, methods are techniques involve
confidential trade secrets or commercial HHS. deploying the closure device from the
property such as patentable material, ACTION: Notice. delivery device such that an endo-
and personal information concerning cameral portion of the closure device
individuals associated with the grant SUMMARY: The inventions listed below self-expands first to cover the hole from
applications, the disclosure of which are owned by an agency of the U.S. the inside, and then extra-cameral arms
would constitute a clearly unwarranted Government and are available for of the device are released to self-deploy
invasion of personal privacy. licensing in the U.S. against the outside of the wall by

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Document Created: 2017-11-02 02:41:19
Document Modified: 2017-11-02 02:41:19

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.
Dates		Submit either electronic or written comments on the collection of information by January 2, 2018.
Contact		Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation		82 FR 50885

82 FR 50885 - Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 211 (November 2, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration