Medical Devices; Medical Device Reporting; Baseline Reports, 33692-33695 [E8-13350]
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33692
Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Rules and Regulations
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 520.538
[Amended]
2. In paragraph (a) of § 520.538,
remove ‘‘25, 75, or 100 milligrams’’ and
in its place add ‘‘25, 50, 75, or 100
milligrams’’.
I
Dated: June 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–13353 Filed 6–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Ivermectin, Fenbendazole, and
Praziquantel Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for the
veterinary prescription use of chewable
tablets containing ivermectin,
fenbendazole, and praziquantel for the
treatment and control of various internal
parasites and for the prevention of
canine heartworm disease in adult dogs.
DATES: This rule is effective June 13,
2008.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed NADA 141–
286 that provides for the veterinary
prescription use of PANACUR Plus
(ivermectin, fenbendazole, and
praziquantel) Soft Chews for the
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treatment and control of various internal
parasites and for the prevention of
canine heartworm disease in adult dogs.
The NADA is approved as of May 9,
2008, and the regulations are amended
in 21 CFR part 520 by adding § 520.1200
to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
The agency has determined under 21
CFR 25.33(d)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
I
2. Add § 520.1200 to read as follows:
§ 520.1200 Ivermectin, fenbendazole, and
praziquantel tablets.
(a) Specifications. Each chewable
tablet contains either:
(1) 68 micrograms (µg) ivermectin,
1.134 grams fenbendazole, and 57
milligrams (mg) praziquantel; or
(2) 27 µg ivermectin, 454 mg
fenbendazole, and 23 mg praziquantel.
(b) Sponsor. See No. 057926 in
§ 510.600(c) of this chapter.
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(c) Conditions of use in dogs—(1)
Amount. Administer tablets to provide
6 µg per kilogram (/kg) ivermectin, 100
mg/kg fenbendazole, and 5 mg/kg
praziquantel.
(2) Indications for use. For the
treatment and control of adult Toxocara
canis (roundworm), Ancylostoma
caninum (hookworm), Trichuris vulpis
(whipworm), and Dipylidium caninum
(tapeworm), and for the prevention of
heartworm disease caused by Dirofilaria
immitis in adult dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: June 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–13354 Filed 6–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA–2008–N–0310]
Medical Devices; Medical Device
Reporting; Baseline Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Direct final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
medical device reporting regulations to
remove a requirement for baseline
reports that the agency deems no longer
necessary. Currently, manufacturers
provide baseline reports to FDA that
include the FDA product code and the
premarket approval or premarket
notification number. Because most of
the information in these baseline reports
is also submitted to FDA in individual
adverse event reports, FDA is removing
the requirement for baseline reports.
The removal of this requirement will
eliminate unnecessary duplication and
reduce the manufacturer’s reporting
burden. FDA is amending the regulation
in accordance with its direct final rule
procedures. Elsewhere in this issue of
the Federal Register, we are publishing
a companion proposed rule under
FDA’s usual procedures for notice and
comment to provide a procedural
framework to finalize the rule in the
event we receive a significant adverse
comment and withdraw this direct final
rule.
DATES: This rule is effective October 27,
2008. Submit written or electronic
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Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Rules and Regulations
comments by August 27, 2008. If we
receive no significant adverse comments
within the specified comment period,
we intend to publish a document
confirming the effective date of the final
rule in the Federal Register within 30
days after the comment period on this
direct final rule ends. If we receive any
timely significant adverse comment, we
will withdraw this final rule in part or
in whole by publication of a document
in the Federal Register within 30 days
after the comment period ends.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2008–N–
0310, by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal, as
described previously, in the ADDRESSES
portion of this document under
Electronic Submissions.
Instructions: All submissions received
must include the agency name and
Docket No. for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see section IX of this
document.
Docket: For access to the docket to
read background documents or
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 Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Howard A. Press, Center for Devices and
Radiological Health (HFZ–530), Food
and Drug Administration, 1350 Piccard
Dr, Rockville, MD 20850, 240–276–
3457.
SUPPLEMENTARY INFORMATION:
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I. What Is the Background of the Rule?
In the Federal Register of December
11, 1995 (60 FR 63578), FDA published
a final rule revising part 803 (21 CFR
part 803) and requiring medical device
manufacturers to submit certain reports
relating to adverse events, including a
requirement under § 803.55 to submit
baseline reports on FDA Form 3417 or
an electronic equivalent. Section 803.55
requires manufacturers to submit
baseline reports when the manufacturer
submits the first adverse event report
under § 803.50 for a device model. In
addition, § 803.55 requires annual
updates of each baseline report.
The baseline report includes address
information for the reporting and
manufacturing site for the device,
device identifiers, the basis for
marketing for the device (e.g., the 510(k)
number or PMA number), the FDA
product code, the shelf life of the device
(if applicable) and the expected life of
the device, the number of devices
distributed each year, and the method
used to calculate that number. In the
Federal Register of July 31, 1996 (61 FR
39868), FDA stayed the requirement for
manufacturers to submit information on
the number of devices distributed each
year and the method used to calculate
that number, because of questions raised
about the feasibility of obtaining such
information and the usefulness of such
information once submitted to FDA.
With the requirement for these two
data elements stayed, the data submitted
in baseline reports largely overlapped
with the data submitted in individual
adverse event reports. That is, FDA had
access to much of the information
included in baseline reports through the
individual adverse event reports
submitted on the MedWatch mandatory
reporting form (FDA Form 3500A). Two
notable exceptions were the basis for
marketing and the FDA product code,
data elements that were included in the
baseline reports but were not included
in the FDA Form 3500A and its
instructions.
The basis for marketing and the FDA
product code were, however,
subsequently incorporated into the FDA
Form 3500A and its instructions. In the
Federal Register of December 27, 2004
(69 FR 77256), FDA announced
proposed modifications to FDA Form
3500A, which included adding an entry
for the basis for marketing (PMA or
510(k) number). In the Federal Register
of December 7, 2005 (70 FR 72843), FDA
announced that the Office of
Management and Budget approved these
modifications under the Paperwork
Reduction Act of 1995. FDA also
modified the instructions for FDA Form
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3500A to state that manufacturers use
the FDA product code when completing
the entry for ‘‘Common Device Name’’
on FDA Form 3500A.
With the addition of these two data
elements (basis for marketing and FDA
product code) to FDA Form 3500A and
its instructions, the information
submitted in FDA Form 3500A largely
replicates the information submitted in
baseline reports. As a result, the agency
deems the baseline reporting
requirement in § 803.55 no longer
necessary. The agency believes that
removing § 803.55 will reduce the
reporting burden for manufacturers
without impairing the agency’s receipt
of device adverse event information.
II. What Does This Direct Final
Rulemaking Do?
In this direct final rule, FDA is
removing § 803.55, which requires
manufacturers to submit a baseline
report when they submit the first report
under § 803.50 involving a device model
and provide annual updates thereafter.
In addition, this direct final rule makes
conforming amendments to §§ 803.1(a),
803.10(c), and 803.58(b) to remove
references to baseline reports and to
§ 803.55. Finally, this direct final rule
removes the terms ‘‘device family’’ and
‘‘shelf life’’ from the definitions in
§ 803.3 because these terms are used
only in the context of baseline reports.
III. What Are the Procedures for Issuing
a Direct Final Rule?
In the Federal Register of November
21, 1997 (62 FR 62466), FDA announced
the availability of the guidance
document entitled ‘‘Guidance for FDA
and Industry: Direct Final Rule
Procedures’’ that described when and
how FDA will employ direct final
rulemaking. We believe that this rule is
appropriate for direct final rulemaking
because it is intended to make
noncontroversial changes to existing
regulations. We anticipate no significant
adverse comment.
Consistent with FDA’s procedures on
direct final rulemaking, we are
publishing elsewhere in this issue of the
Federal Register a companion proposed
rule that is identical to the direct final
rule. The companion proposed rule
provides a procedural framework within
which the rule may be finalized in the
event the direct final rule is withdrawn
because of any significant adverse
comment. The comment period for this
direct final rule runs concurrently with
the comment period of the companion
proposed rule. Any comments received
in response to the companion proposed
rule will also be considered as
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Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Rules and Regulations
comments regarding this direct final
rule.
We are providing a comment period
on the direct final rule of 75 days after
the date of publication in the Federal
Register. If we receive any significant
adverse comment, we intend to
withdraw this final rule before its
effective date by publication of a notice
in the Federal Register within 30 days
after the comment period ends. A
significant adverse comment is defined
as a comment that explains why the rule
would be inappropriate, including
challenges to the rule’s underlying
premise or approach, or would be
ineffective or unacceptable without
change. In determining whether an
adverse comment is significant and
warrants withdrawing a direct final
rulemaking, we will consider whether
the comment raises an issue serious
enough to warrant a substantive
response in a notice-and-comment
process in accordance with section 553
of the Administrative Procedure Act
(APA) (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the
scope of the rule will not be considered
significant or adverse under this
procedure. For example, a comment
recommending an additional change to
the rule will not be considered a
significant adverse comment, unless the
comment states why the rule would be
ineffective without the additional
change. In addition, if a significant
adverse comment applies to part of a
rule and that part can be severed from
the remainder of the rule, we may adopt
as final those parts of the rule that are
not the subject of a significant adverse
comment.
If we withdraw the direct final rule,
all comments received will be
considered under the companion
proposed rule in developing a final rule
under the usual notice-and-comment
procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant
adverse comment during the specified
comment period, we intend to publish
a confirmation document in the Federal
Register within 30 days after the
comment period ends.
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IV. What is the Legal Authority for This
Rule?
FDA is issuing this direct final rule
under the device and general
administrative provisions of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
321, 331, 351, 352, 360i, 371, and 374).
V. What is the Environmental Impact of
This Rule?
The agency has determined under 21
CFR 25.30(h) and (i) that this action is
of a type that does not individually or
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cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
VI. What is the Economic Impact of
This Rule?
FDA has examined the impacts of the
final rule under Executive Order 12866,
the Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Public Law 104–4).
Executive Order 12866 directs agencies
to assess all costs and benefits of
available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
agency believes that this direct final rule
is not a significant regulatory action as
defined by the Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. The direct final rule amends
the existing medical device reporting
regulation to remove § 803.55, which
requires that manufacturers submit
baseline reports, and makes conforming
amendments to §§ 803.1(a), 803.3,
803.10(c), and 803.58(b) to remove
references to baseline reports and to
§ 803.55 and to remove the terms
‘‘device family’’ and ‘‘shelf life.’’ This
final rule does not impose any new
requirements but instead removes a
reporting requirement for manufacturers
that FDA deems no longer necessary.
The agency certifies that the final rule
will not have a significant economic
impact on a substantial number of small
entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $127
million, using the most current (2006)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
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VII. How Does the Paperwork
Reduction Act of 1995 Apply to This
Rule?
This direct final rule contains no
collection of information. Therefore,
clearance by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520) is not required.
VIII. What are the Federalism Impacts
of This Rule?
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
IX. How Do You Submit Comments on
This Rule?
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic comments or submissions
will be accepted by FDA only through
FDMS at https://www.regulations.gov.
List of Subjects in 21 CFR Part 803
Imports, Medical devices, Reporting
and recordkeeping requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 803 is
amended as follows:
PART 803—MEDICAL DEVICE
REPORTING
1. The authority citation for 21 CFR
part 803 continues to read as follows:
I
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Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Rules and Regulations
Authority: 21 U.S.C. 352, 360, 360i, 360j,
371, 374.
§ 803.1
[Amended]
2. Section 803.1 is amended in
paragraph (a), in the fourth sentence, by
removing the phrase ‘‘and baseline
reports’’.
I
§ 803.3
[Amended]
3. Section 803.3 is amended by
removing the definitions for ‘‘Device
family’’ and ‘‘Shelf life’’.
I
§ 803.10
[Amended]
4. Section 803.10 is amended by
removing paragraph (c)(3) and
redesignating paragraph (c)(4) as
paragraph (c)(3).
I
§ 803.55
I
[Removed]
5. Section 803.55 is removed.
§ 803.58
[Amended]
6. Section 803.58 is amended in
paragraph (b)(1) by removing ‘‘803.55,’’.
I
Dated: June 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–13350 Filed 6–12–08; 8:45 am]
BILLING CODE 4160–01–S
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Parts 4022 and 4044
Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets
in Single-Employer Plans; Interest
Assumptions for Valuing and Paying
Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
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AGENCY:
SUMMARY: The Pension Benefit Guaranty
Corporation’s regulations on Benefits
Payable in Terminated Single-Employer
Plans and Allocation of Assets in
Single-Employer Plans prescribe interest
assumptions for valuing and paying
benefits under terminating singleemployer plans. This final rule amends
the regulations to adopt interest
assumptions for plans with valuation
dates in July 2008. Interest assumptions
are also published on the PBGC’s Web
site (https://www.pbgc.gov).
DATES: Effective July 1, 2008.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion, Manager, Regulatory
and Policy Division, Legislative and
Regulatory Department, Pension Benefit
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16:26 Jun 12, 2008
Jkt 214001
Guaranty Corporation, 1200 K Street,
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll-free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: The
PBGC’s regulations prescribe actuarial
assumptions—including interest
assumptions—for valuing and paying
plan benefits of terminating singleemployer plans covered by title IV of
the Employee Retirement Income
Security Act of 1974. The interest
assumptions are intended to reflect
current conditions in the financial and
annuity markets.
Three sets of interest assumptions are
prescribed: (1) A set for the valuation of
benefits for allocation purposes under
section 4044 (found in Appendix B to
Part 4044), (2) a set for the PBGC to use
to determine whether a benefit is
payable as a lump sum and to determine
lump-sum amounts to be paid by the
PBGC (found in Appendix B to Part
4022), and (3) a set for private-sector
pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using the PBGC’s historical
methodology (found in Appendix C to
Part 4022).
This amendment (1) adds to
Appendix B to Part 4044 the interest
assumptions for valuing benefits for
allocation purposes in plans with
valuation dates during July 2008, (2)
adds to Appendix B to Part 4022 the
interest assumptions for the PBGC to
use for its own lump-sum payments in
plans with valuation dates during July
2008, and (3) adds to Appendix C to
Part 4022 the interest assumptions for
private-sector pension practitioners to
refer to if they wish to use lump-sum
interest rates determined using the
PBGC’s historical methodology for
valuation dates during July 2008.
For valuation of benefits for allocation
purposes, the interest assumptions that
the PBGC will use (set forth in
Appendix B to part 4044) will be 5.95
percent for the first 20 years following
the valuation date and 5.02 percent
thereafter. These interest assumptions
represent an increase (from those in
effect for June 2008) of 0.27 percent for
the first 20 years following the valuation
date and 0.27 percent for all years
thereafter.
The interest assumptions that the
PBGC will use for its own lump-sum
payments (set forth in Appendix B to
part 4022) will be 3.50 percent for the
period during which a benefit is in pay
status and 4.00 percent during any years
preceding the benefit’s placement in pay
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33695
status. These interest assumptions
represent an increase from those in
effect for June 2008 of 0.25 percent in
the immediate annuity rate and are
otherwise unchanged. For private-sector
payments, the interest assumptions (set
forth in Appendix C to part 4022) will
be the same as those used by the PBGC
for determining and paying lump sums
(set forth in Appendix B to part 4022).
The PBGC has determined that notice
and public comment on this amendment
are impracticable and contrary to the
public interest. This finding is based on
the need to determine and issue new
interest assumptions promptly so that
the assumptions can reflect current
market conditions as accurately as
possible.
Because of the need to provide
immediate guidance for the valuation
and payment of benefits in plans with
valuation dates during July 2008, the
PBGC finds that good cause exists for
making the assumptions set forth in this
amendment effective less than 30 days
after publication.
The PBGC has determined that this
action is not a ‘‘significant regulatory
action’’ under the criteria set forth in
Executive Order 12866.
Because no general notice of proposed
rulemaking is required for this
amendment, the Regulatory Flexibility
Act of 1980 does not apply. See 5 U.S.C.
601(2).
List of Subjects
29 CFR Part 4022
Employee benefit plans, Pension
insurance, Pensions, Reporting and
recordkeeping requirements.
29 CFR Part 4044
Employee benefit plans, Pension
insurance, Pensions.
I In consideration of the foregoing, 29
CFR parts 4022 and 4044 are amended
as follows:
PART 4022—BENEFITS PAYABLE IN
TERMINATED SINGLE-EMPLOYER
PLANS
1. The authority citation for part 4022
continues to read as follows:
I
Authority: 29 U.S.C. 1302, 1322, 1322b,
1341(c)(3)(D), and 1344.
2. In appendix B to part 4022, Rate Set
177, as set forth below, is added to the
table.
I
Appendix B to Part 4022—Lump Sum
Interest Rates for PBGC Payments
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Agencies
[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Rules and Regulations]
[Pages 33692-33695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13350]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA-2008-N-0310]
Medical Devices; Medical Device Reporting; Baseline Reports
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its medical
device reporting regulations to remove a requirement for baseline
reports that the agency deems no longer necessary. Currently,
manufacturers provide baseline reports to FDA that include the FDA
product code and the premarket approval or premarket notification
number. Because most of the information in these baseline reports is
also submitted to FDA in individual adverse event reports, FDA is
removing the requirement for baseline reports. The removal of this
requirement will eliminate unnecessary duplication and reduce the
manufacturer's reporting burden. FDA is amending the regulation in
accordance with its direct final rule procedures. Elsewhere in this
issue of the Federal Register, we are publishing a companion proposed
rule under FDA's usual procedures for notice and comment to provide a
procedural framework to finalize the rule in the event we receive a
significant adverse comment and withdraw this direct final rule.
DATES: This rule is effective October 27, 2008. Submit written or
electronic
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comments by August 27, 2008. If we receive no significant adverse
comments within the specified comment period, we intend to publish a
document confirming the effective date of the final rule in the Federal
Register within 30 days after the comment period on this direct final
rule ends. If we receive any timely significant adverse comment, we
will withdraw this final rule in part or in whole by publication of a
document in the Federal Register within 30 days after the comment
period ends.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0310, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see section IX of this document.
Docket: For access to the docket to read background documents or
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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Howard A. Press, Center for Devices
and Radiological Health (HFZ-530), Food and Drug Administration, 1350
Piccard Dr, Rockville, MD 20850, 240-276-3457.
SUPPLEMENTARY INFORMATION:
I. What Is the Background of the Rule?
In the Federal Register of December 11, 1995 (60 FR 63578), FDA
published a final rule revising part 803 (21 CFR part 803) and
requiring medical device manufacturers to submit certain reports
relating to adverse events, including a requirement under Sec. 803.55
to submit baseline reports on FDA Form 3417 or an electronic
equivalent. Section 803.55 requires manufacturers to submit baseline
reports when the manufacturer submits the first adverse event report
under Sec. 803.50 for a device model. In addition, Sec. 803.55
requires annual updates of each baseline report.
The baseline report includes address information for the reporting
and manufacturing site for the device, device identifiers, the basis
for marketing for the device (e.g., the 510(k) number or PMA number),
the FDA product code, the shelf life of the device (if applicable) and
the expected life of the device, the number of devices distributed each
year, and the method used to calculate that number. In the Federal
Register of July 31, 1996 (61 FR 39868), FDA stayed the requirement for
manufacturers to submit information on the number of devices
distributed each year and the method used to calculate that number,
because of questions raised about the feasibility of obtaining such
information and the usefulness of such information once submitted to
FDA.
With the requirement for these two data elements stayed, the data
submitted in baseline reports largely overlapped with the data
submitted in individual adverse event reports. That is, FDA had access
to much of the information included in baseline reports through the
individual adverse event reports submitted on the MedWatch mandatory
reporting form (FDA Form 3500A). Two notable exceptions were the basis
for marketing and the FDA product code, data elements that were
included in the baseline reports but were not included in the FDA Form
3500A and its instructions.
The basis for marketing and the FDA product code were, however,
subsequently incorporated into the FDA Form 3500A and its instructions.
In the Federal Register of December 27, 2004 (69 FR 77256), FDA
announced proposed modifications to FDA Form 3500A, which included
adding an entry for the basis for marketing (PMA or 510(k) number). In
the Federal Register of December 7, 2005 (70 FR 72843), FDA announced
that the Office of Management and Budget approved these modifications
under the Paperwork Reduction Act of 1995. FDA also modified the
instructions for FDA Form 3500A to state that manufacturers use the FDA
product code when completing the entry for ``Common Device Name'' on
FDA Form 3500A.
With the addition of these two data elements (basis for marketing
and FDA product code) to FDA Form 3500A and its instructions, the
information submitted in FDA Form 3500A largely replicates the
information submitted in baseline reports. As a result, the agency
deems the baseline reporting requirement in Sec. 803.55 no longer
necessary. The agency believes that removing Sec. 803.55 will reduce
the reporting burden for manufacturers without impairing the agency's
receipt of device adverse event information.
II. What Does This Direct Final Rulemaking Do?
In this direct final rule, FDA is removing Sec. 803.55, which
requires manufacturers to submit a baseline report when they submit the
first report under Sec. 803.50 involving a device model and provide
annual updates thereafter. In addition, this direct final rule makes
conforming amendments to Sec. Sec. 803.1(a), 803.10(c), and 803.58(b)
to remove references to baseline reports and to Sec. 803.55. Finally,
this direct final rule removes the terms ``device family'' and ``shelf
life'' from the definitions in Sec. 803.3 because these terms are used
only in the context of baseline reports.
III. What Are the Procedures for Issuing a Direct Final Rule?
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how FDA will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial changes to existing regulations. We
anticipate no significant adverse comment.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule that is identical to the direct final rule. The companion
proposed rule provides a procedural framework within which the rule may
be finalized in the event the direct final rule is withdrawn because of
any significant adverse comment. The comment period for this direct
final rule runs concurrently with the comment period of the companion
proposed rule. Any comments received in response to the companion
proposed rule will also be considered as
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comments regarding this direct final rule.
We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comment, we intend to withdraw this
final rule before its effective date by publication of a notice in the
Federal Register within 30 days after the comment period ends. A
significant adverse comment is defined as a comment that explains why
the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553). Comments that are frivolous, insubstantial, or outside the scope
of the rule will not be considered significant or adverse under this
procedure. For example, a comment recommending an additional change to
the rule will not be considered a significant adverse comment, unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
If we withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant adverse comment during the
specified comment period, we intend to publish a confirmation document
in the Federal Register within 30 days after the comment period ends.
IV. What is the Legal Authority for This Rule?
FDA is issuing this direct final rule under the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 331, 351, 352, 360i, 371, and 374).
V. What is the Environmental Impact of This Rule?
The agency has determined under 21 CFR 25.30(h) and (i) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. What is the Economic Impact of This Rule?
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this direct final rule is not a significant regulatory action as
defined by the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The direct final rule amends the existing medical
device reporting regulation to remove Sec. 803.55, which requires that
manufacturers submit baseline reports, and makes conforming amendments
to Sec. Sec. 803.1(a), 803.3, 803.10(c), and 803.58(b) to remove
references to baseline reports and to Sec. 803.55 and to remove the
terms ``device family'' and ``shelf life.'' This final rule does not
impose any new requirements but instead removes a reporting requirement
for manufacturers that FDA deems no longer necessary. The agency
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?
This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not
required.
VIII. What are the Federalism Impacts of This Rule?
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
IX. How Do You Submit Comments on This Rule?
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments or
submissions will be accepted by FDA only through FDMS at https://
www.regulations.gov.
List of Subjects in 21 CFR Part 803
Imports, Medical devices, Reporting and recordkeeping requirements.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
803 is amended as follows:
PART 803--MEDICAL DEVICE REPORTING
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1. The authority citation for 21 CFR part 803 continues to read as
follows:
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Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Sec. 803.1 [Amended]
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2. Section 803.1 is amended in paragraph (a), in the fourth sentence,
by removing the phrase ``and baseline reports''.
Sec. 803.3 [Amended]
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3. Section 803.3 is amended by removing the definitions for ``Device
family'' and ``Shelf life''.
Sec. 803.10 [Amended]
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4. Section 803.10 is amended by removing paragraph (c)(3) and
redesignating paragraph (c)(4) as paragraph (c)(3).
Sec. 803.55 [Removed]
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5. Section 803.55 is removed.
Sec. 803.58 [Amended]
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6. Section 803.58 is amended in paragraph (b)(1) by removing
``803.55,''.
Dated: June 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13350 Filed 6-12-08; 8:45 am]
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