Alzchem Trostberg GmbH; Filing of Food Additive Petition (Animal Use), 65717-65718 [2019-25904]
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Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Proposed Rules
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comment does not include any
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Submit written/paper submissions as
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• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
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Drug Administration, 5630 Fishers
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• 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–F–4399 for ‘‘Zinpro Corp.; Filing
of Food Additive Petition (Animal
Use).’’ 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
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contact information to be made publicly
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and other applicable disclosure law. For
more information about FDA’s posting
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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.
FOR FURTHER INFORMATION CONTACT:
Chelsea Cerrito, Center for Veterinary
Medicine, Food and Drug
Administration (HFV–224), 7519
Standish Pl., Rockville, MD 20855, 240–
402–6729, Chelsea.Cerrito@fda.hhs.gov.
In the
Federal Register of September 22, 2017
(82 FR 44367), FDA announced that
Zinpro Corp., 10400 Viking Dr., Suite
240, Eden Prairie, MN 55344 had filed
a petition (FAP 2300) proposing to
amend Title 21 of the Code of Federal
Regulations (CFR) in part 573 (21 CFR
part 573) Food Additives Permitted in
Feed and Drinking Water of Animals to
provide for the safe use of chromium
DL-methionine as a nutritional source of
chromium in cattle feed. Zinpro has
amended the petition by changing the
feeding rate.
Zinpro has submitted a revised
environmental assessment which the
Agency is placing on public display at
the Dockets Management Staff for public
review and comment (see DATES and
ADDRESSES).
SUPPLEMENTARY INFORMATION:
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25903 Filed 11–27–19; 8:45 am]
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65717
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA–2019–F–5401]
Alzchem Trostberg GmbH; Filing of
Food Additive Petition (Animal Use)
AGENCY:
Food and Drug Administration,
HHS.
Notification; petition for
rulemaking.
ACTION:
The Food and Drug
Administration (FDA or we) is
announcing that Alzchem Trostberg
GmbH has filed a petition proposing
that the food additive regulations be
amended to provide for the safe use of
guanidinoacetic acid as a precursor of
creatine in poultry feeds.
DATES: The food additive petition was
filed on September 25, 2019.
ADDRESSES: For access to the docket, 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:
Carissa Adams, Center for Veterinary
Medicine, Food and Drug
Administration,7519 Standish Pl.,
Rockville, MD 20855, 240–402–6283,
Carissa.Adams@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 2309) has been filed by
Alzchem Trostberg GmbH,
CHEMIEPARK TROSTBERG, Dr.-AlbertFrank-Str. 32, 83308 Trostberg,
Germany. The petition proposes to
amend Title 21 of the Code of Federal
Regulations (CFR) in part 573 (21 CFR
part 573) Food Additives Permitted in
Feed and Drinking Water of Animals to
provide for the safe use of
guanidinoacetic acid as a precursor of
creatine in poultry feeds.
The petitioner has claimed that this
action is categorically excluded under
21 CFR 25.32(r) because it is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. In addition,
the petitioner has stated that, to their
knowledge, no extraordinary
circumstances exist. If FDA determines
a categorical exclusion applies, neither
an environmental assessment nor an
environmental impact statement is
SUMMARY:
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Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Proposed Rules
required. If FDA determines a
categorical exclusion does not apply, we
will request an environmental
assessment and make it available for
public inspection.
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25904 Filed 11–27–19; 8:45 am]
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DEPARTMENT OF DEFENSE
Office of the Secretary
I. Executive Summary
32 CFR Part 199
A. Purpose of the Proposed Rule
The purpose of this rule is to propose
TRICARE regulation modifications
necessary to implement for Ambulatory
Surgery Centers (ASC) and Cancer and
Children’s Hospitals (CCHs) the
statutory requirement that payments for
TRICARE institutional services ‘‘shall be
determined to the extent practicable in
accordance with the same
reimbursement rules as apply to
payments to providers of services of the
same type under [Medicare].’’ Although
Medicare’s reimbursement methods for
ASC and CCHs are different, it is
prudent to propose adopting both the
Medicare ASC system and to adopt the
Outpatient Prospective Payment System
(OPPS) with hold-harmless adjustments
(meaning the provider is not reimbursed
less than their costs) for CCHs
simultaneously to align with our
statutory requirement to reimburse like
Medicare at the same time. This rule
sets forth the proposed regulatory
modifications necessary to implement
TRICARE reimbursement methodologies
similar to those applicable to Medicare
beneficiaries for outpatient services
rendered in ASCs and cancer and
children’s hospitals.
1. TRICARE proposes adopting the
Medicare reimbursement methodology
for ASCs. Currently, TRICARE
reimburses surgical services performed
in TRICARE authorized ambulatory
surgery settings (i.e., freestanding ASCs
and other TRICARE providers exempt
from the TRICARE OPPS reimbursement
methodology including cancer and
children’s hospitals) institutional
facility costs on the basis of
prospectively determined amounts, in
accordance with Title 32 Code of
Federal Regulations (CFR) 199.14(d).
The current system was modeled after
Medicare’s previous ASC
reimbursement system. TRICARE’s
current reimbursement system for
services provided in these ambulatory
surgery settings is based on Medicare’s
retired system, and is difficult to
[Docket ID: DOD–2019–HA–0056]
RIN 0720–AB73
TRICARE; Reimbursement of
Ambulatory Surgery Centers and
Outpatient Services Provided in
Cancer and Children’s Hospitals
Office of the Secretary,
Department of Defense (DoD).
ACTION: Proposed rule.
AGENCY:
The Department of Defense,
Defense Health Agency, is proposing to
amend its reimbursement of ambulatory
surgery centers (ASC) and outpatient
services provided in Cancer and
Children’s Hospitals (CCHs). Proposed
revisions are in accordance with the
TRICARE Statute that requires
TRICARE’s payment methods for
institutional care be determined, to the
extent practicable, in accordance with
the same reimbursement rules as apply
to payments to providers of services of
the same type under Medicare. In
accordance with this requirement,
TRICARE proposes to adopt Medicare’s
payment methodology for ASC, and
adopt Medicare’s payment methodology
for outpatient services provided in
CCHs.
DATES: Written comments received at
the address indicated below by January
28, 2020 will be accepted.
ADDRESSES: You may submit comments,
identified by docket number and/or
Regulatory Information Number (RIN)
number and title, by either of the
following methods:
• Federal Rulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Department of Defense, Office
of the Chief Management Officer,
Directorate for Oversight and
Compliance, 4800 Mark Center Drive,
Mailbox #24, Suite 08D09, Alexandria,
VA 22350–1700.
Instructions: All submissions received
must include the agency name and
SUMMARY:
khammond on DSKJM1Z7X2PROD with PROPOSALS
docket number or RIN for this Federal
Register document. The general policy
for comments and other submissions
from members of the public is to make
these submissions available for public
viewing on the internet at https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
FOR FURTHER INFORMATION CONTACT: Elan
Green, Defense Health Agency, 303–
676–3907.
SUPPLEMENTARY INFORMATION:
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update. Adoption of Medicare’s ASC
reimbursement system will bring
TRICARE reimbursement for ambulatory
surgery care into alignment with the
statutory requirement that payment
methods for institutional care be, to the
extent practicable, in accordance with
the same reimbursement rules used by
Medicare.
2. TRICARE proposes to adopt the
Medicare payment methodology for
outpatient services provided in CCHs. In
a final rule, published December 10,
2008 (73 FR 74945–74966), TRICARE
adopted Medicare’s payment
methodology for outpatient hospital
services—the Outpatient Prospective
Payment System (OPPS). Under
Medicare, CCHs were held harmless and
were paid the full amount of the
decrease they experienced (as prior to
OPPS the hospital had been paid 100%
of their costs) after the implementation
of OPPS, under section 1833(t)(7) of the
Social Security Act. These payments are
transitional outpatient payments
(TOPs). Because of the complexity and
because of the administrative burden/
expense of calculating and maintaining
the TOPs, TRICARE opted to totally
exempt CCHs from OPPS initially. The
agency is now revisiting the exemption
of CCHs from OPPS. In this proposed
rule, we propose that TRICARE adopt
the Medicare methodology for
reimbursement of outpatient facility
services (including ambulatory surgery)
rendered in a cancer or children’s
hospital, with modifications to address
the administrative burden and
complexity. The Defense Health Agency
(DHA) now has the capability, and it is
feasible, to adopt these reimbursement
provisions with a modification that the
hold-harmless provisions will be
calculated annually, rather than in
monthly interim payments.
B. Summary of the Major Provisions of
the Proposed Rule
1. Adopting Medicare’s Ambulatory
Surgical Center Reimbursement System
for TRICARE Authorized Ambulatory
Surgery Centers. Per Title 10 United
States Code (U.S.C.), 1079(i)(2),
TRICARE’s payment methods for
institutional care shall be determined, to
the extent practicable, in accordance
with the same reimbursement rules used
by Medicare. Under this proposed rule,
TRICARE will reimburse ASCs for
ambulatory surgical services using a
method similar to Medicare’s ASC
reimbursement methodology. Under the
proposed TRICARE ASC reimbursement
method, payment for a TRICARE patient
will be made at the lower of the billed
charge or the Medicare-determined ASC
payment rate with applicable TRICARE
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[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Proposed Rules]
[Pages 65717-65718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25904]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2019-F-5401]
Alzchem Trostberg GmbH; Filing of Food Additive Petition (Animal
Use)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; petition for rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that Alzchem Trostberg GmbH has filed a petition proposing that the
food additive regulations be amended to provide for the safe use of
guanidinoacetic acid as a precursor of creatine in poultry feeds.
DATES: The food additive petition was filed on September 25, 2019.
ADDRESSES: For access to the docket, 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: Carissa Adams, Center for Veterinary
Medicine, Food and Drug Administration,7519 Standish Pl., Rockville, MD
20855, 240-402-6283, [email protected].
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a
food additive petition (FAP 2309) has been filed by Alzchem Trostberg
GmbH, CHEMIEPARK TROSTBERG, Dr.-Albert-Frank-Str. 32, 83308 Trostberg,
Germany. The petition proposes to amend Title 21 of the Code of Federal
Regulations (CFR) in part 573 (21 CFR part 573) Food Additives
Permitted in Feed and Drinking Water of Animals to provide for the safe
use of guanidinoacetic acid as a precursor of creatine in poultry
feeds.
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r) because it is of a type that does not
individually or cumulatively have a significant effect on the human
environment. In addition, the petitioner has stated that, to their
knowledge, no extraordinary circumstances exist. If FDA determines a
categorical exclusion applies, neither an environmental assessment nor
an environmental impact statement is
[[Page 65718]]
required. If FDA determines a categorical exclusion does not apply, we
will request an environmental assessment and make it available for
public inspection.
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25904 Filed 11-27-19; 8:45 am]
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