Agency Information Collection Request. 30-Day Public Comment Request, 43858-43859 [2020-15585]
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Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
instead established a tolerance of 30 ppb
for QCA, and granted the supplemental
approval for carbadox. Subsequent to
the 1998 supplemental approval, CVM
has evaluated additional information
that undermines its previous
conclusions that carcinogenic residues
deplete within 72 hours and that QCA
is the only residue detectable at 72
hours postdosing. These new data
reinforce the inadequacy of the
currently approved method and clarify
the need for a method that satisfies the
requirements of part 500. See, supra,
Section II.C.
B. The Current Approved Method for
Carbadox That Measures QCA as the
Marker Residue for Carbadox Is
Inadequate
Under section 512(d)(1)(I) of the
FD&C Act, carcinogenic new animal
drugs, such as carbadox, must have a
method of detection, prescribed or
approved by regulation, to ensure that
no residue of carcinogenic concern
persists in any edible tissue or other
food derived from a treated animal.
CVM has implemented this statutory
requirement through its SOM
regulations in part 500, subpart E,
which require that each carcinogenic
new animal drug have a marker residue
with a known relationship to the
residue of carcinogenic concern. This
relationship is necessary to establish a
concentration of the marker residue (the
Rm) that ensures any residue of
carcinogenic concern in a specific
edible tissue is below the level
corresponding to maximum lifetime risk
of cancer in the test animal of 1 in 1
million (the Sm), based on calculations
that consider the entire diet (the So).
The approved method must have a limit
of detection less than or equal to the Rm.
Although CVM approved the current
method for carbadox as part of the
supplemental NADA in January 1998
and designated the Sm and So, we did
not require the sponsor to provide data
showing the relationship between QCA
and the residue of carcinogenic concern
and therefore did not designate an Rm.
Nor did we require the sponsor to
identify a regulatory method with a
limit of detection less than or equal to
the Rm. Without an Rm and an
appropriate regulatory method for
detecting when the marker residue falls
below the Rm, it is impossible to
determine that the residue of
carcinogenic concern falls below the Sm
and So at the established withdrawal
the current regulations, step (4) requires the
development of a method that complies with the
operational definition of no residue (the method’s
LOD is less than or equal to the Rm).
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period. Accordingly, it is impossible,
based on information currently
available, to use the current approved
method to ensure compliance with the
operational definition of no residue.
Furthermore, based on studies
conducted since 1998, CVM has
reevaluated the conclusions that
originally led us to determine that
assignment of a tolerance of 30 ppb for
QCA in swine liver would assure that
the residue of carcinogenic concern
would remain below their respective So
in all edible tissues. CVM concludes,
based on its review of the data, that
carcinogenic residues persist longer
than previously known. Because there is
no regulatory method that detects when
the residue of carcinogenic concern falls
below the limit of detection for the Rm,
the current approved method is
inadequate for monitoring compliance
with FDA’s operational definition of no
residue. See § 500.84(c)(3). Accordingly,
the approved method for carbadox does
not satisfy the statutory or regulatory
requirements.
IV. Conclusion
In the January 1998 approval of the
supplemental NADA for carbadox, CVM
previously determined that carbadox
and its metabolites, including DCBX,
induce cancer in animals but that no
such residues of the drug would be
found in edible tissues after the
preslaughter withdrawal period by the
approved regulatory methods of
examination. However, the failure to
establish an Rm or a relationship
between QCA residues and residue of
carcinogenic concern in animal tissue
during the 1998 process leads CVM to
now conclude that the current approved
method does not meet the requirements
of the FD&C Act and the SOM
regulations and is inadequate to monitor
carbadox residues in compliance with
FDA’s operational definition of no
residue. New information available to
CVM since the approval of the January
1998 supplemental NADA reinforces the
importance of having an approved
regulatory method that complies with
the SOM regulations. Therefore, we are
proposing to revoke the current
approved method.
V. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
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Register, but websites are subject to
change over time.
1. Sua´rez, A.F. and Arnold, D., Addendum to
the carbadox monograph prepared by the
36th meeting of the Committee and
published in the FAO Food and
Nutrition Paper 41/3, Rome 1991.
Available at: https://www.fao.org/
fileadmin/user_upload/vetdrug/docs/4115-carbadox.pdf (accessed on April 7,
2020).
2. Evaluations of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA).
Carbadox. Available at: https://
apps.who.int/food-additivescontaminants-jecfa-database/
chemical.aspx?chemID=2176 (accessed
on April 7, 2020).
3. Internet Archive of Health Canada, Drug
and Health Products (June 2008), https://
web.archive.org/web/20080609050022/
https://www.hc-sc.gc.ca/dhp-mps/vet/faq/
faq_mrl-lmr-eng.php (accessed on April
7, 2020).
4. Australian Pesticides and Veterinary
Medicines Authority, ‘‘Substances not
permitted for use on food-producing
animals in Australia,’’ https://
apvma.gov.au/node/11626 (accessed on
April 7, 2020).
Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15246 Filed 7–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–0278]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before August 19, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
SUMMARY:
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43859
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
comments or requesting information,
please include the document identifier
0990–0278 and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
Protections is requesting a three year
extension of the Federal wide Assurance
(FWA) form. The FWA is designed to
provide a simplified procedure for
institutions engaged in HHS-conducted
or supported research to satisfy the
assurance requirements of Section
491(a) of the Public Health Service Act
and HHS Regulations for the protection
of human subjects at 45 CFR 46.103.
Respondents are institutions engaged
in human subject’s research that is
conducted or supported by HHS.
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Federal wide
Assurance Form.
Type of Collection: Extension.
OMB No. 0990–0278—Office of the
Assistant Secretary for Health, Office
for Human Research Protections—
Federal Wide Assurance Form
Abstract: Assistant Secretary for
Health, Office for Human Research
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses per
respondent
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total
burden hours
Federal wide Assurance (FWA) .......................................................................
14,000
2.0
0.50
14,000
Total ..........................................................................................................
........................
........................
........................
14,000
Terry Clark,
Office of the Secretary, Asst Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2020–15585 Filed 7–17–20; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Privacy Act of 1974; System of
Records
Department of Health and
Human Services.
ACTION: Notice of a New System of
Records, and Rescindment of a System
of Records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, the Department of Health
and Human Services (HHS) is
establishing a new department-wide
system of records, 09–90–2001, Records
Used for Surveillance and Study of
Epidemics, Preventable Diseases and
Problems. The new system of records
replaces, and is broader than, a similar
system of records maintained by HHS’
Centers for Disease Control and
Prevention (CDC), which HHS is
rescinding in this notice, 09–20–0113
Epidemic Investigation Case Records.
DATES: The new department-wide
system of records is applicable July 20,
2020, subject to a 30-day period in
which to comment on the routine uses.
The rescindment of the CDC system of
records is applicable August 19, 2020.
Submit any comments by August 19,
2020.
SUMMARY:
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The public should address
written comments by email to
beth.kramer@hhs.gov or by mail to Beth
Kramer, HHS Privacy Act Officer, FOIA/
Privacy Act Division, Office of the
Assistant Secretary for Public Affairs,
200 Independence Ave. SW,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
General questions about the new system
of records and the related rescindments
may be submitted by email to
beth.kramer@hhs.gov or by mail to Beth
Kramer, HHS Privacy Act Officer, FOIA/
Privacy Act Division, Office of the
Assistant Secretary for Public Affairs,
200 Independence Ave. SW,
Washington, DC 20201.
SUPPLEMENTARY INFORMATION: In the
winter and spring of 2020, spread of the
novel coronavirus, SARS–CoV–2, which
causes the disease known as COVID–19,
required HHS to expand its
recordkeeping in order to respond to the
pandemic. Prior to 2020, CDC
maintained records about
epidemiological studies and
surveillance of disease problems.
However, HHS’ experience during the
COVID–19 pandemic made clear that
other components, not just CDC, must
collect epidemiologic and public health
surveillance records about individuals
to support the Department’s response.
For example, the Office of the Assistant
Secretary for Health (OASH) is
managing records about tests for
COVID–19 or its antibodies, some of
which are subject to the Privacy Act.
Therefore, the Department has
decided to expand the existing system
ADDRESSES:
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of records of the CDC, 09–20–0113
Epidemic Investigation Case Records,
and re-establish it under a new system
number and name as a department-wide
system of records covering all parts of
the Department that may maintain
epidemiological and surveillance
records necessary to support the
Department’s response to the pandemic.
The new department-wide system of
records includes the records covered in
CDC system of records 09–20–0113,
which HHS rescinds in this notice, but
is broader in that it covers records used
for surveillance and investigation of
epidemics, preventable diseases and
health problems maintained by any
component of HHS, not just CDC. This
department-wide system of records
notice (SORN) differs from the CDC
SORN it is replacing in these additional
respects:
• It is formatted to comply with OMB
Circular A–108.
• The System Manager section
includes updated contacts for CDC
records, and adds contacts for OASH
records and ‘‘records maintained by
other HHS components.’’
• The Authorities section includes
one additional authority not included in
the CDC SORN: 42 U.S.C. 247d–6d.
• The Purpose description is
department-wide.
• The Categories of Individuals
section uses different wording from, but
identifies the same categories of
individuals as, the CDC SORN.
• The Categories of Records section
identifies the categories as ‘‘medical
records and related documents,’’
including ‘‘case reports, lab requisition
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]]>Agencies
[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43858-43859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15585]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-0278]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before August 19,
2020.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting
[[Page 43859]]
comments or requesting information, please include the document
identifier 0990-0278 and project title for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Federal wide Assurance Form.
Type of Collection: Extension.
OMB No. 0990-0278--Office of the Assistant Secretary for Health, Office
for Human Research Protections--Federal Wide Assurance Form
Abstract: Assistant Secretary for Health, Office for Human Research
Protections is requesting a three year extension of the Federal wide
Assurance (FWA) form. The FWA is designed to provide a simplified
procedure for institutions engaged in HHS-conducted or supported
research to satisfy the assurance requirements of Section 491(a) of the
Public Health Service Act and HHS Regulations for the protection of
human subjects at 45 CFR 46.103.
Respondents are institutions engaged in human subject's research
that is conducted or supported by HHS.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Federal wide Assurance (FWA).................... 14,000 2.0 0.50 14,000
---------------------------------------------------------------
Total....................................... .............. .............. .............. 14,000
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2020-15585 Filed 7-17-20; 8:45 am]
BILLING CODE 4150-28-P
