Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date, 58874-58875 [E8-23717]
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58874
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations
(iii) Free-choice feeds—(A) Amount. 5
mg/kg body weight (2.27 mg/lb),
including the following formulations:
Ingredient1
Percent
(1) Free-choice, dry Type C feed:
Salt (sodium chloride)
Monosodium phosphate
Dried cane molasses
Zinc sulfate
Copper sulfate
Fenbendazole 20% Type A article
(2) Free-choice, dry Type C feed:
Salt (sodium chloride)
Dicalcium phosphate (18.5% P)
Calcium carbonate (38% Ca)
Magnesium oxide (56% Mg)
Zinc sulfate
Mineral oil
Dried cane molasses (46% sugars)
Potassium iodide
Fenbendazole 20% Type A article
(3) Free-choice, liquid Type C feed:
Cane molasses2
Water
Urea solution, 55%
Phosphoric acid 75% (feed grade)
Xantham gum
Trace minerals
Vitamin premix
Fenbendazole 20% Type A article
International Feed No.
59.00
31.16
3.12
0.76
0.45
5.51
6–04–152
6–04–288
4–04–695
6–05–556
6–01–720
n/a
35.93
32.44
15.93
10.14
1.47
1.00
0.98
0.01
2.10
6–04–152
6–00–080
6–01–069
6–02–756
6–05–556
8–03–123
4–04–695
6–03–759
n/a
80.902
9.36
7.05
2.00
0.20
0.20
0.01
0.278
4–13–251
n/a
5–05–707
6–03–707
8–15–818
n/a
n/a
n/a
1The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer
for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the freechoice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
regulations (see 21 CFR 573.920).
2The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to
the industry standard of 79.5 brix.
(B) Indications for use. As in
paragraph (e)(3)(i) of this section.
(C) Limitations. Feed a total of 5 mg
of fenbendazole per kg (2.27 mg/lb) of
body weight to cattle over a 3- to 6-day
period. Retreatment may be needed after
4 to 6 weeks. Cattle must not be
slaughtered within 13 days following
last treatment. For dairy cattle the milk
discard time is zero hours. A
withdrawal period has not been
established for this product in preruminating calves. Do not use in calves
to be processed for veal.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–23845 Filed 10–7–08; 8:45 am]
SUMMARY: The Food and Drug
Administration (FDA) is confirming the
effective date of October 15, 2008, for
the final rule that appeared in the
Federal Register of June 2, 2008 (73 FR
31358). The direct final rule amends the
hearing aid labeling to reference the
most recent version of the consensus
standard used to determine the
technical data to be included in labeling
for hearing aids. This document
confirms the effective date of the direct
final rule.
DATES: Effective date confirmed:
October 15, 2008.
dwashington3 on PRODPC61 with RULES
BILLING CODE 4160–01–S
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Food and Drug Administration
21 CFR Part 801
[Docket No. FDA–2008–N–0148]
Medical Devices; Hearing Aids;
Technical Data Amendments;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Direct final rule; confirmation
of effective date.
ACTION:
PO 00000
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Eric
A. Mann, Center for Devices and
Radiological Health (HFZ–460), Food
and Drug Administration,9200
Corporate Blvd., Rockville, MD 20850,
240–276–4242.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 2, 2008 (73 FR
31358), FDA solicited comments
concerning the direct final rule for a 75day period ending August 18, 2008.
FDA stated that the effective date of the
direct final rule would be on October
15, 2008, 60 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA
received one letter of comment on the
direct final rule. However, this comment
does not constitute a significant adverse
comment. Therefore, FDA is confirming
the effective date of the direct final rule.
The comment received and FDA’s
response to the comment are discussed
as follows:
The only comment on the direct final
rule requested clarification regarding
the applicability of the proposed change
in the standard of the American
National Standards Institute to hearing
aid models that were tested and
characterized prior to the effective date
FOR FURTHER INFORMATION CONTACT:
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58875
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations
of the direct final rule on October 15,
2008. The comment interpreted the
proposed change as being only
prospectively applied to new models
undergoing test procedures on or after
the effective date of the proposed
change. FDA agrees that the proposed
change applies only to new hearing aid
models undergoing characterization on
or after the effective date of October 15,
2008; hearing aid models tested prior to
this date are subject only to the
characterization standard cited in the
regulation at the time they were tested.
Authority: Therefore, under the Federal
Food, Drug, and Cosmetic Act and the Public
Health Service Act, and under authority
delegated to the Commissioner of Food and
Drugs, the amendments issued thereby
become effective on October 15, 2008.
Dated: October 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–23717 Filed 10–7–08; 8:45 am]
BILLING CODE 4160–01–S
ACTION:
MMS–4058 are correctly identified as
shown below in the table at § 210.10.
Correcting amendment.
SUMMARY: The MMS published a final
rule in the Federal Register on
Wednesday, March 26, 2008 (73 FR
15885), announcing amendments to
existing regulations for reporting
production and royalties on oil, gas,
coal and other solid minerals, and
geothermal resources produced from
Federal and Indian leases. This
docutment corrects the final rule, which
contained a clerical error in the tables
identifying OMB-approved information
collections and their corresponding
forms.
Effective Date: Effective on
October 8, 2008.
DATES:
Minerals Management Service
[Docket No. MMS–2008–MRM–0021]
30 CFR Part 210
RIN 1010–AD20
Reporting Amendments
Minerals Management Service
(MMS), Interior.
AGENCY:
Hyla
Hurst, Regulatory Specialist, Minerals
Management Service, Minerals Revenue
Management, P.O. Box 25165, MS
302B2, Denver, Colorado 80225;
telephone (303) 231–3495; or e-mail
Hyla.Hurst@mms.gov.
FOR FURTHER INFORMATION CONTACT:
A final
rule was published in the Federal
Register on March 26, 2008 (73 FR
15885) containing a clerical error in the
preamble and the regulatory text in the
tables listing OMB-approved
information collections. The forms
approved under OMB Control Number
1010–0139 were incorrectly identified
on page 15889 in the preamble and page
15893 in the regulatory text. Both tables
contain the same error. Form MMS–
4054 (Parts A, B, and C) and Form
OMB Control No. and short title
Coal, Solid minerals, Continental
Shelf, Electronic funds transfers,
Geothermal energy, Government
contracts, Indian lands, Mineral
royalties, Natural gas, Penalties,
Petroleum, Oil and gas, Public lands—
mineral resources, Reporting and
recordkeeping requirements.
Accordingly, 30 CFR Part 210 is
corrected by making the following
amendments:
■
PART 210—FORMS AND REPORTS
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF THE INTERIOR
List of Subjects in 30 CFR Part 210
1. The authority citation for part 210
continues to read as follows:
■
Authority: 5 U.S.C. 301 et. seq. ; 25 U.S.C.
396, 2107; 30 U.S.C. 189, 190, 359, 1023,
1751(a); 31 U.S.C. 3716, 9701; 43 U.S.C.
1334, 1801 et. seq. ; and 44 U.S.C. 3506(a).
2. In § 210.10, the table is amended by
revising the entry for OMB number
1010–0139 to read as follows:
■
§ 210.10 What are the OMB-approved
information collections?
*
*
*
*
*
Form or information collected
*
*
1010–0139, 30 CFR Parts 210 and 216, Production Accounting.
*
*
*
*
Form MMS–4054 (Parts A, B, and C), Oil and Gas Operations Report.
*
Form MMS–4058, Production Allocation Schedule Report.
*
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*
Dated: September 30, 2008.
C. Stephen Allred,
Assistant Secretary for Land and Minerals
Management.
[FR Doc. E8–23788 Filed 10–7–08; 8:45 am]
*
*
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AM95
BILLING CODE 4310–MR–P
dwashington3 on PRODPC61 with RULES
Dental Care—Provision of One-Time
Outpatient Dental Care for Certain
Veterans
*
*
eligible veterans following discharge or
release from active duty. In section 1709
of Public Law 110–181, the National
Defense Authorization Act for Fiscal
Year 2008, Congress amended the
eligibility criteria for the one-time
dental treatment benefit. This rule is
necessary to incorporate the statutory
amendments into VA regulations.
Effective Date: October 8, 2008.
AGENCY:
DATES:
ACTION:
FOR FURTHER INFORMATION CONTACT:
Tony Guagliardo, Director, Business
Policy, Chief Business Office (163),
Veterans Health Administration,
Department of Veterans Affairs, 810
Department of Veterans Affairs.
Final rule.
SUMMARY: The Department of Veterans
Affairs (VA) is amending its regulations
regarding the authority to provide onetime outpatient dental treatment to
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]]>Agencies
[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Rules and Regulations]
[Pages 58874-58875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23717]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
[Docket No. FDA-2008-N-0148]
Medical Devices; Hearing Aids; Technical Data Amendments;
Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of October 15, 2008, for the final rule that appeared in
the Federal Register of June 2, 2008 (73 FR 31358). The direct final
rule amends the hearing aid labeling to reference the most recent
version of the consensus standard used to determine the technical data
to be included in labeling for hearing aids. This document confirms the
effective date of the direct final rule.
DATES: Effective date confirmed: October 15, 2008.
FOR FURTHER INFORMATION CONTACT: Eric A. Mann, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration,9200
Corporate Blvd., Rockville, MD 20850, 240-276-4242.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 2, 2008 (73
FR 31358), FDA solicited comments concerning the direct final rule for
a 75-day period ending August 18, 2008. FDA stated that the effective
date of the direct final rule would be on October 15, 2008, 60 days
after the end of the comment period, unless any significant adverse
comment was submitted to FDA during the comment period. FDA received
one letter of comment on the direct final rule. However, this comment
does not constitute a significant adverse comment. Therefore, FDA is
confirming the effective date of the direct final rule. The comment
received and FDA's response to the comment are discussed as follows:
The only comment on the direct final rule requested clarification
regarding the applicability of the proposed change in the standard of
the American National Standards Institute to hearing aid models that
were tested and characterized prior to the effective date
[[Page 58875]]
of the direct final rule on October 15, 2008. The comment interpreted
the proposed change as being only prospectively applied to new models
undergoing test procedures on or after the effective date of the
proposed change. FDA agrees that the proposed change applies only to
new hearing aid models undergoing characterization on or after the
effective date of October 15, 2008; hearing aid models tested prior to
this date are subject only to the characterization standard cited in
the regulation at the time they were tested.
Authority: Therefore, under the Federal Food, Drug, and Cosmetic
Act and the Public Health Service Act, and under authority delegated
to the Commissioner of Food and Drugs, the amendments issued thereby
become effective on October 15, 2008.
Dated: October 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23717 Filed 10-7-08; 8:45 am]
BILLING CODE 4160-01-S
