FDA Regulations; Technical Amendment, 49941-49943 [E8-19654]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations
provide information at the time of entry
of the merchandise on the entry
summary form, CBP Form 7501, as to
whether the value of the imported
merchandise was determined on the
basis of the price paid by the buyer in
the ‘‘first or earlier sale.’’ The likely
respondents are business organizations
including importers and brokers. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a valid control number
assigned by OMB. This collection of
information falls under the previously
approved collection 1651–0022 for the
Entry Summary, CBP Form 7501.
Signing Authority
This document is being issued in
accordance with § 0.1(a)(1) of title 19 of
the Code of Federal Regulations (19 CFR
0.1(a)(1)) pertaining to the authority of
the Secretary of the Treasury (or his/her
delegate) to approve regulations related
to certain customs revenue functions.
List of Subjects in 19 CFR Part 141
Customs duties and inspection, Entry
of merchandise, Reporting and
recordkeeping requirements.
Amendments to the Regulations
For the reasons stated above, part 141
of title 19 of the Code of Federal
Regulations (19 CFR part 141) is
amended as set forth below.
I
PART 141—ENTRY OF MERCHANDISE
1. The general authority citation for
part 141 continues to read, and the
specific authority for § 141.16 is added,
to read as follows:
I
Authority: 19 U.S.C. 66, 1448, 1484, 1624.
*
*
*
*
*
Section 141.61 also issued under sec.
15422(a), Pub. L. 110–234, 122 Stat. 1547 (19
U.S.C. 1484 note) and 19 U.S.C. 1401a.
*
*
*
*
*
2. Section 141.61 is amended by
adding a new paragraph (g) to read as
follows:
I
§ 141.61 Completion of entry and entry
summary documentation.
ebenthall on PRODPC60 with RULES
*
*
*
*
*
(g) Declaration of value. Pursuant to
section 15422(a) of the Food,
Conservation, and Energy Act of 2008
(Pub. L. 110–234), for all goods entered
for consumption or withdrawn from
warehouse for consumption from
August 20, 2008 through August 19,
2009, an importer of merchandise must
enter an ‘‘F’’ next to the declared value
on CBP Form 7501, or the electronic
filing equivalent, when the declared
transaction value of the imported
VerDate Aug<31>2005
14:53 Aug 22, 2008
Jkt 214001
merchandise is determined on the basis
of the price paid by the buyer in a sale
occurring earlier than the last sale prior
to the introduction of the merchandise
into the United States.
W. Ralph Basham,
Commissioner, U.S. Customs and Border
Protection.
Approved: August 20, 2008.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. E8–19640 Filed 8–20–08; 4:15 pm]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16, 610, 640, 812, 814,
822, and 860
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
I. Background
FDA is amending 21 CFR 16.1 to
correct an inaccurate citation and is
amending 21 CFR 610.51 and 21 CFR
640.53 to correct typographical errors.
FDA is also amending its medical
device regulations in 21 CFR 812, 814,
and 860 to include references to and
mailing addresses for CBER and CDER,
Fmt 4700
Sfmt 4700
21 CFR Part 610
Biologics, Labeling, Reporting and
recordkeeping requirements.
21 CFR Part 640
SUMMARY: The Food and Drug
Administration (FDA) is amending a
regulatory hearing process regulation to
correct an inaccurate citation, and
regulations pertaining to biological
products to correct two typographical
errors. FDA is also amending certain
medical device regulations to include
references to and mailing address
information for the Center for Biologics
Evaluation and Research (CBER), Center
for Drug Evaluation and Research
(CDER), and Center for Devices and
Radiological Health (CDRH). This action
is being taken to ensure the accuracy of
FDA’s regulations.
DATES: This rule is effective August 25,
2008.
FOR FURTHER INFORMATION CONTACT:
´
Denise Sanchez, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
Frm 00009
List of Subjects
Administrative practice and
procedure.
FDA Regulations; Technical
Amendment
PO 00000
and 21 CFR 822.8 to correct an
inadvertent omission of the mailing
address for CDRH. Submissions
regarding a medical device must be sent
to the address of the appropriate center
that has regulatory responsibility for the
medical device. Therefore, FDA is
updating these regulations to include
address information for all appropriate
centers.
Publication of this document
constitutes final action under the
Administrative Procedures Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because this amendment to the
regulations provides only technical
changes to correct an inaccurate citation
and typographical errors, and to update
mailing addresses and other
information, and is nonsubstantive.
21 CFR Part 16
[Docket No. FDA–2008–N–0423]
AGENCY:
49941
Blood, Labeling, Reporting and
recordkeeping requirements.
21 CFR Part 812
Health records, Medical devices,
Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 814
Administrative practice and
procedure, Confidential business
information, Medical devices, Medical
research, Reporting and recordkeeping
requirements.
21 CFR Part 822
Medical devices, Reporting and
recordkeeping requirements.
21 CFR Part 860
Administrative practice and
procedure, Medical devices.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act, and Public
Health Service Act, and under authority
delegated to the Commissioner of Food
and Drugs, 21 CFR parts 16, 610, 640,
812, 814, 822, and 860 are amended as
follows:
PART 16—REGULATORY HEARING
BEFORE THE FOOD AND DRUG
ADMINISTRATION
1. The authority citation for 21 CFR
part 16 continues to read as follows:
I
E:\FR\FM\25AUR1.SGM
25AUR1
49942
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations
Authority: 15 U.S.C. 1451–1461; 21 U.S.C.
141–149, 321–394, 467f, 679, 821, 1034; 28
U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
10. Section 814.42 is amended by
revising the fourth sentence of
paragraph (d)(2) to read as follows:
2. Section 16.1 is amended in
paragraph (b)(2), by removing
‘‘§ 1270.15(e)’’ and adding in its place
‘‘§ 1270.43(e)’’.
I
I
PART 610—GENERAL BIOLOGICAL
PRODUCTS STANDARDS
3. The authority citation for 21 CFR
part 610 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360c, 360d, 360h, 360i, 371,
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
[Amended]
4. Section 610.53 is amended in
paragraph (c) in the table, under column
A, by removing the words
‘‘Cryoprecipitated AFH’’ and adding in
their place ‘‘Cryoprecipitated AHF.’’
I
PART 640—ADDITIONAL STANDARDS
FOR HUMAN BLOOD AND BLOOD
PRODUCTS
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371; 42 U.S.C. 216, 262, 263, 263a,
264.
[Amended]
6. Section 640.51 is amended in
paragraph (b) by removing the word
‘‘Plasmaphersis’’ and adding in its place
‘‘Plasmapheresis.’’
I
PART 812—INVESTIGATIONAL
DEVICE EXEMPTIONS
Authority: 21 U.S.C. 331, 351, 352, 353,
355, 360, 360c–360f, 360h–360j, 371, 372,
374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b–263n.
8. Section 812.20 is amended by
revising paragraph (d) to read as
follows:
I
Application.
ebenthall on PRODPC60 with RULES
*
*
*
*
(d) Information previously submitted.
Information previously submitted to the
Center for Devices and Radiological
Health, the Center for Biologics
Evaluation and Research, or the Center
for Drug Evaluation and Research, as
applicable, in accordance with this
chapter ordinarily need not be
resubmitted, but may be incorporated by
reference.
14:53 Aug 22, 2008
Jkt 214001
Purpose and scope.
*
*
*
*
(c) * * *
(2) Submitting an HDE to the Office of
Device Evaluation (ODE), Center for
Devices and Radiological Health
(CDRH), the Center for Biologics
Evaluation and Research (CBER), or the
Center for Drug Evaluation and Research
(CDER), as applicable.
*
*
*
*
*
I 12. Section 814.104 is amended by
revising paragraph (d) to read as
follows:
Original applications.
*
7. The authority citation for 21 CFR
part 812 continues to read as follows:
VerDate Aug<31>2005
§ 814.100
§ 814.104
I
*
*
*
*
*
(d) * * *
(2) * * * If FDA does not reverse its
decision not to file the PMA, the
applicant may request reconsideration
of the decision from the Director of the
Center for Devices and Radiological
Health, the Director of the Center for
Biologics Evaluation and Research, or
the Director of the Center for Drug
Evaluation and Research, as applicable.
* * *
*
*
*
*
*
I 11. Section 814.100 is amended by
revising paragraph (c)(2) to read as
follows:
*
5. The authority citation for 21 CFR
part 640 continues to read as follows:
I
§ 812.20
Filing a PMA.
*
I
§ 640.51
I
9. The authority citation for 21 CFR
part 814 continues to read as follows:
I
[Amended]
§ 610.53
PART 822—POSTMARKET
SURVEILLANCE
§ 814.42
§ 16.1
(3) For devices regulated by the
Center for Drug Evaluation and
Research, send this information to the
Central Document Control Room, Center
for Drug Evaluation and Research, Food
and Drug Administration, 5901–B
Ammendale Rd., Beltsville, MD 20705–
1266.
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
*
*
*
*
(d) Address for submissions and
correspondence. Copies of all original
HDEs amendments and supplements, as
well as any correspondence relating to
an HDE, must be sent or delivered to the
following:
(1) For devices regulated by the
Center for Devices and Radiological
Health, send this information to the
Document Mail Center (HFZ–401),
Office of Device Evaluation, Center for
Devices and Radiological Health, Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850.
(2) For devices regulated by the
Center for Biologics Evaluation and
Research, send this information to the
Document Control Center (HFM–99),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
13. The authority citation for 21 CFR
part 822 continues to read as follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l,
371, 374.
14. Section 822.8 is amended by
adding a sentence after the first sentence
to read as follows:
I
§ 822.8 When, where, and how must I
submit my postmarket surveillance plan?
* * * For devices regulated by the
Center for Devices and Radiological
Health, send three copies of your
submission to the Postmarket
Surveillance Document Center (HFZ–
541), Epidemiology Branch, Center for
Devices and Radiological Health, Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850–
3229. * * *
PART 860—MEDICAL DEVICE
CLASSIFICATION PROCEDURES
15. The authority citation for 21 CFR
part 860 continues to read as follows:
I
Authority: 21 U.S.C. 360c, 360d, 360e,
360i, 360j, 371, 374.
16. Section 860.7 is amended by
revising paragraph (g)(4) to read as
follows:
I
§ 860.7 Determination of safety and
effectiveness.
*
*
*
*
*
(g) * * *
(4) Required information that has
been submitted previously to the Center
for Devices and Radiological Health, the
Center for Biologics Evaluation and
Research, or the Center for Drug
Evaluation and Research, as applicable,
need not be resubmitted, but may be
incorporated by reference.
I 17. Section 860.123 is amended by
revising paragraph (b)(1) to read as
follows:
§ 860.123 Reclassification petition:
Content and form.
*
*
*
*
*
(b) * * *
(1) For devices regulated by the
Center for Devices and Radiological
Health, addressed to the Food and Drug
Administration, Center for Devices and
Radiological Health, Regulations Staff
E:\FR\FM\25AUR1.SGM
25AUR1
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations
(HFZ–215), 1350 Piccard Dr., Rockville,
MD 20857; for devices regulated by the
Center for Biologics Evaluation and
Research, addressed to the Document
Control Center (HFM–99), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448; for devices regulated
by the Center for Drug Evaluation and
Research, addressed to the Central
Document Control Room, Center for
Drug Evaluation and Research, Food
and Drug Administration, 5901–B
Ammendale Rd., Beltsville, MD 20705–
1266, as applicable.
*
*
*
*
*
authority for deciding claims worth less
than $5,000.
This rule amends section 304.10(b) to
provide that the Chief Financial Officer
will make final determinations for
claims worth less than $5,000.
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19654 Filed 8–22–08; 8:45 am]
PEACE CORPS
22 CFR Part 304
RIN 0420–AA23
Claims Against the Government Under
the Federal Tort Claims Act
Peace Corps.
ACTION: Final rule.
ebenthall on PRODPC60 with RULES
AGENCY:
SUMMARY: The Peace Corps is revising
its regulation concerning claims filed
under the Federal Tort Claims Act, to
make the regulation internally
consistent with another provision
stating that the Chief Financial Officer
has authority to approve claims for
amounts under $5000.
DATES: The final rule is effective
September 24, 2008.
FOR FURTHER INFORMATION CONTACT:
Nancy G. Miller, Associate General
Counsel, Office of the General Counsel,
202–692–2150.
SUPPLEMENTARY INFORMATION: The Peace
Corps published a proposed rule on July
9, 2008, for public review and comment.
See 73 FR 39270, (July 9, 2008). The
Peace Corps received no public
comments and the Agency has made no
further revisions. Therefore, this rule is
final and will be effective on the date
stated above.
On March 16, 2007, Peace Corps
revised 22 CFR 304.7 to provide that the
Chief Financial Officer ‘‘has the
authority to adjust, determine,
compromise, and settle claims for less
than $5,000.’’ This final rule will rectify
an omission in sec. 304.10 which did
not refer to the Chief Financial Officer’s
14:53 Aug 22, 2008
Financial Officer will make the written
determination.
Dated: August 18, 2008.
Tyler Posey,
General Counsel.
[FR Doc. E8–19642 Filed 8–22–08; 8:45 am]
BILLING CODE 6015–01–P
This regulation has been determined
to be non-significant within the
meaning of Executive Order 12866.
DEPARTMENT OF THE INTERIOR
Jkt 214001
Regulatory Flexibility Act of 1980 (5
U.S.C. 605(b))
Minerals Management Service
This regulatory action will not have a
significant adverse impact on a
substantial number of small entities.
30 CFR Parts 203, 250, 251, 256, 280,
281, and 290
Unfunded Mandates Act of 1995 (Sec.
202, Pub. L. 104–4)
RIN 1010–AD43
This regulatory action does not
contain a Federal mandate that will
result in the expenditure by state, local,
and tribal governments, in aggregate, or
by the private sector of $100 million or
more in any one year.
Electronic Payment of Fees for Outer
Continental Shelf Activities
Paperwork Reduction Act of 1995 (44
U.S.C., Chapter 35)
BILLING CODE 4160–01–S
VerDate Aug<31>2005
Executive Order 12866
49943
SUMMARY: This final rule requires that
all lessees, operators, permittees, and
right-of-way holders pay all fees for
processing plans, applications, and
permits electronically. This rule will aid
industry in payment processing and
reduce payment processing errors. This
rule will improve MMS processing
efficiency and facilitate the correction of
industry payment errors. The MMS will
not accept checks, money orders, or
cashier’s checks for payment of fees
after the effective date of this final rule.
The final rule also adjusts certain cost
recovery fees for inflation.
DATES: Effective Date: This rule becomes
effective on September 24, 2008.
FOR FURTHER INFORMATION CONTACT: Kirk
Malstrom, Office of Offshore Regulatory
Programs, Regulations and Standards
Branch, (703) 787–1751.
SUPPLEMENTARY INFORMATION:
This regulatory action will not impose
any additional reporting or
recordkeeping requirements under the
Paperwork Reduction Act.
Federalism (Executive Order 13132)
This regulatory action does not have
Federalism implications, as set forth in
Executive Order 13132. It will not 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.
List of Subjects in 22 CFR Part 304
Claims.
Accordingly, Peace Corps amends 22
CFR part 304 as follows:
I
PART 304—CLAIMS AGAINST THE
GOVERNMENT UNDER THE FEDERAL
TORT CLAIMS ACT
1. The authority citation for part 304
continues to read as follows:
I
Authority: 28 U.S.C. 2672; 22 U.S.C.
2503(b); E.O. 12137, as amended.
2. Amend § 304.10 by revising
paragraph (b) to read as follows:
I
§ 304.10
Review of claim.
*
*
*
*
*
(b) After legal review and
recommendation by the General
Counsel, the Director of the Peace Corps
will make a written determination on
the claim, unless the claim is worth less
than $5,000, in which case the Chief
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
[Docket ID: MMS–2007–OMM–0065]
Minerals Management Service
(MMS), Interior.
ACTION: Final rule.
AGENCY:
Background
The MMS published a proposed rule
on December 21, 2007 (72 FR 72648),
that would require all lessees, operators,
pipeline right-of-way (ROW) holders,
and permittees to submit payments for
cost recovery service fees electronically.
The comment period for the proposed
rule closed February 19, 2008, and
Chevron submitted the one and only
comment on the proposed rule. The
commenter supports the concept of
submitting fees electronically through
Pay.gov. The commenter stated
concerns about only using Pay.gov and
provided rule language to allow
alternatives for a different payment
portal if so needed. The MMS believes
Pay.gov to be the best option for paying
E:\FR\FM\25AUR1.SGM
25AUR1
]]>Agencies
[Federal Register Volume 73, Number 165 (Monday, August 25, 2008)]
[Rules and Regulations]
[Pages 49941-49943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19654]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16, 610, 640, 812, 814, 822, and 860
[Docket No. FDA-2008-N-0423]
FDA Regulations; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending a
regulatory hearing process regulation to correct an inaccurate
citation, and regulations pertaining to biological products to correct
two typographical errors. FDA is also amending certain medical device
regulations to include references to and mailing address information
for the Center for Biologics Evaluation and Research (CBER), Center for
Drug Evaluation and Research (CDER), and Center for Devices and
Radiological Health (CDRH). This action is being taken to ensure the
accuracy of FDA's regulations.
DATES: This rule is effective August 25, 2008.
FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is amending 21 CFR 16.1 to correct an inaccurate citation and
is amending 21 CFR 610.51 and 21 CFR 640.53 to correct typographical
errors.
FDA is also amending its medical device regulations in 21 CFR 812,
814, and 860 to include references to and mailing addresses for CBER
and CDER, and 21 CFR 822.8 to correct an inadvertent omission of the
mailing address for CDRH. Submissions regarding a medical device must
be sent to the address of the appropriate center that has regulatory
responsibility for the medical device. Therefore, FDA is updating these
regulations to include address information for all appropriate centers.
Publication of this document constitutes final action under the
Administrative Procedures Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only technical changes to correct an inaccurate
citation and typographical errors, and to update mailing addresses and
other information, and is nonsubstantive.
List of Subjects
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 640
Blood, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 822
Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 860
Administrative practice and procedure, Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public
Health Service Act, and under authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 16, 610, 640, 812, 814, 822, and 860
are amended as follows:
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
1. The authority citation for 21 CFR part 16 continues to read as
follows:
[[Page 49942]]
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
Sec. 16.1 [Amended]
0
2. Section 16.1 is amended in paragraph (b)(2), by removing ``Sec.
1270.15(e)'' and adding in its place ``Sec. 1270.43(e)''.
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
0
3. The authority citation for 21 CFR part 610 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
Sec. 610.53 [Amended]
0
4. Section 610.53 is amended in paragraph (c) in the table, under
column A, by removing the words ``Cryoprecipitated AFH'' and adding in
their place ``Cryoprecipitated AHF.''
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
0
5. The authority citation for 21 CFR part 640 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.
Sec. 640.51 [Amended]
0
6. Section 640.51 is amended in paragraph (b) by removing the word
``Plasmaphersis'' and adding in its place ``Plasmapheresis.''
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
0
7. The authority citation for 21 CFR part 812 continues to read as
follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b-263n.
0
8. Section 812.20 is amended by revising paragraph (d) to read as
follows:
Sec. 812.20 Application.
* * * * *
(d) Information previously submitted. Information previously
submitted to the Center for Devices and Radiological Health, the Center
for Biologics Evaluation and Research, or the Center for Drug
Evaluation and Research, as applicable, in accordance with this chapter
ordinarily need not be resubmitted, but may be incorporated by
reference.
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
9. The authority citation for 21 CFR part 814 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
0
10. Section 814.42 is amended by revising the fourth sentence of
paragraph (d)(2) to read as follows:
Sec. 814.42 Filing a PMA.
* * * * *
(d) * * *
(2) * * * If FDA does not reverse its decision not to file the PMA,
the applicant may request reconsideration of the decision from the
Director of the Center for Devices and Radiological Health, the
Director of the Center for Biologics Evaluation and Research, or the
Director of the Center for Drug Evaluation and Research, as applicable.
* * *
* * * * *
0
11. Section 814.100 is amended by revising paragraph (c)(2) to read as
follows:
Sec. 814.100 Purpose and scope.
* * * * *
(c) * * *
(2) Submitting an HDE to the Office of Device Evaluation (ODE),
Center for Devices and Radiological Health (CDRH), the Center for
Biologics Evaluation and Research (CBER), or the Center for Drug
Evaluation and Research (CDER), as applicable.
* * * * *
0
12. Section 814.104 is amended by revising paragraph (d) to read as
follows:
Sec. 814.104 Original applications.
* * * * *
(d) Address for submissions and correspondence. Copies of all
original HDEs amendments and supplements, as well as any correspondence
relating to an HDE, must be sent or delivered to the following:
(1) For devices regulated by the Center for Devices and
Radiological Health, send this information to the Document Mail Center
(HFZ-401), Office of Device Evaluation, Center for Devices and
Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850.
(2) For devices regulated by the Center for Biologics Evaluation
and Research, send this information to the Document Control Center
(HFM-99), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448.
(3) For devices regulated by the Center for Drug Evaluation and
Research, send this information to the Central Document Control Room,
Center for Drug Evaluation and Research, Food and Drug Administration,
5901-B Ammendale Rd., Beltsville, MD 20705-1266.
PART 822--POSTMARKET SURVEILLANCE
0
13. The authority citation for 21 CFR part 822 continues to read as
follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
0
14. Section 822.8 is amended by adding a sentence after the first
sentence to read as follows:
Sec. 822.8 When, where, and how must I submit my postmarket
surveillance plan?
* * * For devices regulated by the Center for Devices and
Radiological Health, send three copies of your submission to the
Postmarket Surveillance Document Center (HFZ-541), Epidemiology Branch,
Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. * * *
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES
0
15. The authority citation for 21 CFR part 860 continues to read as
follows:
Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
0
16. Section 860.7 is amended by revising paragraph (g)(4) to read as
follows:
Sec. 860.7 Determination of safety and effectiveness.
* * * * *
(g) * * *
(4) Required information that has been submitted previously to the
Center for Devices and Radiological Health, the Center for Biologics
Evaluation and Research, or the Center for Drug Evaluation and
Research, as applicable, need not be resubmitted, but may be
incorporated by reference.
0
17. Section 860.123 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 860.123 Reclassification petition: Content and form.
* * * * *
(b) * * *
(1) For devices regulated by the Center for Devices and
Radiological Health, addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Regulations Staff
[[Page 49943]]
(HFZ-215), 1350 Piccard Dr., Rockville, MD 20857; for devices regulated
by the Center for Biologics Evaluation and Research, addressed to the
Document Control Center (HFM-99), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448; for devices regulated by the Center for
Drug Evaluation and Research, addressed to the Central Document Control
Room, Center for Drug Evaluation and Research, Food and Drug
Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as
applicable.
* * * * *
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19654 Filed 8-22-08; 8:45 am]
BILLING CODE 4160-01-S
