Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 34401-34402 [2019-15269]
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34401
Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
Hampshire Ave., Bldg. 22, Rm. 2169,
Silver Spring, MD 20993–0002, 240–
402–2628.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Advanced Prostate Cancer: Developing
Gonadotropin-Releasing Hormone
Analogues.’’ This draft guidance
describes the FDA’s current
recommendations regarding the overall
development program and clinical trial
designs for developing GnRH analogues
to treat advanced prostate cancer.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Advanced Prostate Cancer:
Developing Gonadotropin-Releasing
Hormone Analogues.’’ 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This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 21 CFR part 312 has been
approved under OMB control number
0910–0014. The collections of
information in 21 CFR parts 50 and 56
(‘‘Protection of Human Subjects:
Informed Consent; Institutional Review
Boards’’) have been approved under
OMB control number 0910–0755. The
collections of information in 21 CFR
parts 201.56 and 201.57 (Prescription
Drug Labeling) have been approved
under OMB control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St. North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
[FR Doc. 2019–15268 Filed 7–17–19; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0427]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Inspection by Accredited Persons
Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 19,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0510. Also
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002 and the FDA Amendments Act of
2007; Accreditation Criteria
OMB Control Number 0910–0510—
Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Pub. L. 107–250) was signed into law
on October 26, 2002. Section 201 of
MDUFMA added a new paragraph (g) to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
374), directing FDA to accredit third
parties (accredited persons) to conduct
inspections of eligible manufacturers of
class II or class III devices. FDA’s
guidance document entitled ‘‘Inspection
by Accredited Persons Under The
Medical Device User Fee and
Modernization Act of 2002 and the FDA
Amendments Act of 2007; Accreditation
Criteria’’ 1 provides information for
those interested in participating in this
voluntary program.
In the Federal Register of March 14,
2019 (84 FR 9352), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Section of the FD&C Act; Activity
Number of
respondents
Number of responses per
respondent
Total annual
responses
Average burden per response
Total hours
704(g); Request for Accreditation ........................................
1
1
1
80
80
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
1 https://www.fda.gov/ucm/groups/fdagov-public/
@fdagov-meddev-gen/documents/document/
ucm089721.pdf.
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Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15269 Filed 7–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: The National
Health Service Corps Loan Repayment
Program, OMB No. 0915–0127—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 for opportunity
for public comment on proposed data
collection projects, HRSA announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this ICR should be
received no later than September 16,
2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail them to
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The National Health Service Corps Loan
Repayment Program, OMB No. 0915–
0127—Revision.
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SUMMARY:
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Abstract: The National Health Service
Corps (NHSC) Loan Repayment Program
(LRP) was established to assure an
adequate supply of trained primary care
health professionals to provide services
in the neediest Health Professional
Shortage Areas (HPSAs) of the United
States. The NHSC Substance Use
Disorder (SUD) Workforce LRP and the
NHSC Rural Community LRP were
established to recruit and retain a health
professional workforce with specific
training and credentials to provide
evidence-based SUD treatment in
HPSAs. Under these programs, HHS
agrees to repay the qualifying
educational loans of selected primary
care health professionals. In return, the
health professionals agree to serve for a
specified period of time in a NHSCapproved site located in a federallydesignated HPSA approved by the
Secretary for LRP participants. The
forms utilized by each LRP include the
following: (1) The NHSC LRP
Application, the Authorization for
Disclosure of Loan Information form, (2)
the Privacy Act Release Authorization
form, and, if applicable, (3) the
Verification of Disadvantaged
Background form, and (4) the Private
Practice Option form. The first three of
the aforementioned NHSC LRP forms
collect information that is needed for
selecting participants and repaying
qualifying educational loans. The last
referenced form, the Private Practice
Option Form, is needed to collect
information for all participants who
have applied for that service option.
NHSC-approved sites are health care
facilities that provide comprehensive
outpatient, ambulatory, primary health
care services to populations residing in
HPSAs. Related in-patient services may
be provided by NHSC-approved Critical
Access Hospitals and Indian Health
Service hospitals. In order to become an
NHSC-approved site, new sites must
submit a Site Application for review
and approval. Existing NHSC-approved
sites are required to complete a Site
Recertification Application every 3
years in order to maintain their NHSCapproved status. Both the NHSC Site
Application and Site Recertification
Application request information on the
clinical service site, sponsoring agency,
recruitment contact, staffing levels,
service users, charges for services,
employment policies, and fiscal
management capabilities. Assistance in
completing these applications may be
obtained through the appropriate State
Primary Care Office and the NHSC. The
information collected on the
applications is used for determining the
eligibility of sites for the assignment of
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NHSC health professionals and to verify
the need for NHSC clinicians. NHSC
service site approval is valid for 3 years.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to assess
an LRP applicant’s eligibility and
qualifications for the LRP, and to obtain
information for NHSC site applicants.
The NHSC LRP application asks for
personal, professional, and financial/
loan information.
The proposed revisions in this ICR
include asking applicants to provide
their educational information on the
completion of advanced training such as
the Primary Care Training and
Enhancement (PCTE) Champion
fellowship. To identify the PCTE
Champions, the NHSC will require
applicants to respond to the following
additional questions and submit their
National Practitioner Identifier (NPI):
(1) Have you completed a fellowship?
(2) Applicants who selected ‘‘yes’’ to
the question above are required to
submit the NPI number.
NHSC policy requires behavioral
health providers to practice in a
community-based setting that provides
access to comprehensive behavioral
health services. Accordingly, for those
sites seeking to be assigned behavioral
health NHSC participants, additional
site information will be collected from
an NHSC Comprehensive Behavioral
Health Services Checklist. NHSC sites
that do not directly offer all required
behavioral health services must
demonstrate a formal affiliation with a
comprehensive, community-based
primary behavioral health setting or
facility to provide these services.
Likely Respondents: Likely
respondents include: (1) Licensed
primary care medical, dental, and
mental and behavioral health providers
who are employed or seeking
employment, and are interested in
serving underserved populations; (2)
health care facilities interested in
participating in the NHSC and becoming
an NHSC-approved service site; and (3)
NHSC sites providing behavioral health
care services directly, or through a
formal affiliation with a comprehensive
community-based primary behavioral
health setting or facility providing
comprehensive behavioral health
services.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
E:\FR\FM\18JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34401-34402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15269]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0427]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Inspection by Accredited Persons Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
19, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0510.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Inspection by Accredited Persons Program Under the Medical Device User
Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007;
Accreditation Criteria
OMB Control Number 0910-0510--Extension
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Pub. L. 107-250) was signed into law on October 26, 2002. Section 201
of MDUFMA added a new paragraph (g) to section 704 of the Federal,
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 374), directing FDA
to accredit third parties (accredited persons) to conduct inspections
of eligible manufacturers of class II or class III devices. FDA's
guidance document entitled ``Inspection by Accredited Persons Under The
Medical Device User Fee and Modernization Act of 2002 and the FDA
Amendments Act of 2007; Accreditation Criteria'' \1\ provides
information for those interested in participating in this voluntary
program.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm089721.pdf.
---------------------------------------------------------------------------
In the Federal Register of March 14, 2019 (84 FR 9352), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Section of the FD&C Act; Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
704(g); Request for Accreditation.................................. 1 1 1 80 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 34402]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15269 Filed 7-17-19; 8:45 am]
BILLING CODE 4164-01-P
