The Commerce Control List, 45927 [2012-18967]
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Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–18516 Filed 8–1–12; 8:45 am]
BILLING CODE 4910–13–P
Food and Drug Administration
DEPARTMENT OF COMMERCE
21 CFR Part 807
Bureau of Industry and Security
[Docket No. FDA–2009–N–0114]
RIN 0910–AF88
15 CFR Part 774
The Commerce Control List
CFR Correction
In Title 15 of the Code of Federal
Regulations, Parts 300 to 799, revised as
of January 1, 2012, in supplement no. 1
to part 774, in Category 6, make the
following corrections:
1. In 6A001:
■ A. On page 807, in the note following
paragraph 6A001.a.1, add ‘‘equipment
as follows’’ after ‘‘6A001.a.1 does not
control’’.
■ B. On page 807, in paragraph a.1.a.1.a,
remove ‘‘20’’ and add ‘‘20°’’ in its place.
■ C. On page 810, designating the notes
following 6A001.b.2 as ‘‘Note 1’’ and
‘‘Note 2’’.
■ D. On page 810, removing the note to
6A001.a.2 following the N.B. at the end
of the section.
■
2. In 6A992, on page 826, in the table
for ‘‘License Requirements’’, remove the
entry for RS and place it below the table
as an indented paragraph.
■
3. In 6B108, on page 830, remove
‘‘Unit: r’’ and add ‘‘Unit: Number’’ in its
place.
■
4. In 6C005, on page 831, add
‘‘License Requirements’’ above ‘‘Reason
for Control’’.
■
5. In 6D001, on page 831, remove
‘‘CIV: * * *’’ and add ‘‘CIV: N/A’’ in its
place.
■
6. In 6D003:
A. On page 832, in ‘‘Reason for
Control’’, after ‘‘NS’’, add ‘‘RS,’’.
■ B. On page 833, remove paragraphs
h.1.a and h.1.b.
■
■
7. In 6E001, on page 834, add
‘‘License Requirements’’ above ‘‘Reason
for Control’’.
sroberts on DSK5SPTVN1PROD with RULES
■
8. In 6E002, on page 835, add
‘‘License Requirements’’ above ‘‘Reason
for Control’’.
■
[FR Doc. 2012–18967 Filed 8–1–12; 8:45 am]
BILLING CODE 1505–01–D
VerDate Mar<15>2010
16:21 Aug 01, 2012
Jkt 226001
Implementation of Device Registration
and Listing Requirements Enacted in
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002, the Medical
Device User Fee and Modernization
Act of 2002, and Title II of the Food and
Drug Administration Amendments Act
of 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending its
regulations to reflect recent statutory
amendments to the device registration
and listing provisions of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). The Food and Drug
Administration Amendments Act of
2007 (FDAAA), enacted on September
27, 2007, amended the FD&C Act by
requiring domestic and foreign device
establishments to begin submitting their
registration and device listing
information to FDA by electronic means
rather than on paper forms, and also
specified the timeframes when
establishments are required to submit
such information. In addition, this final
rule would facilitate FDA’s collection of
additional registration information from
foreign establishments as required by
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (Bioterrorism
Act). The final rule will update certain
provisions in the regulations to improve
the quality of registration and listing
information available to FDA. FDA
relies on having complete and accurate
registration and listing information in
order to accomplish a number of
important public health objectives.
DATES: This final rule is effective
October 1, 2012.
FOR FURTHER INFORMATION CONTACT:
Ann Ferriter, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2680,
Silver Spring, MD 20993–0002, 301–
796–5686; and
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
SUMMARY:
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
45927
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Overview of the Final Rule
III. Comments on the Proposed Rule
IV. Legal Authority
V. Analysis of Economic Impacts
VI. Paperwork Reduction Act of 1995
VII. Environmental Impact
VIII. Federalism
IX. References
I. Background
We originally published
establishment registration regulations
for medical devices in the Federal
Register of September 3, 1976 (41 FR
37458) (proposed rule) and August 23,
1977 (42 FR 42520) (final rule), and
device listing regulations in the Federal
Register of September 30, 1977 (42 FR
52808) (proposed rule), and August 25,
1978 (43 FR 37990) (final rule).
These regulations called for
establishment registration and device
listing information to be submitted to
the Center for Devices and Radiological
Health (CDRH) on several paper forms:
FDA 2891, Registration of Device
Establishment; FDA 2891a, Annual
Registration of Device Establishment;
and FDA 2892, Device Listing. Once
these forms were completed and
submitted to FDA, FDA then forwarded
them to a data entry contractor who
entered the information into FDA’s
device registration and listing database.
In June 2002, section 321 of the
Bioterrorism Act (Pub. L. 107–188)
amended section 510(i) of the FD&C Act
(21 U.S.C. 360(i)) to require those
foreign establishments who are required
to register with FDA to do so by
electronic means, and to include
additional information identifying
certain parties involved in the
importation of the foreign
establishment’s devices into the United
States as part of their registration.
Subsequently, in October 2002, section
207 of the Medical Device User Fee and
Modernization Act (MDUFMA) (Pub. L.
107–250) further amended section 510
of the FD&C Act by extending the
requirement for electronic submission of
registration information to include
domestic firms as well as foreign firms.
However, when adding these new
electronic submission requirements,
which appear in section 510(p) of the
FD&C Act, Congress chose to delay their
implementation so that FDA would
have an opportunity to first put systems
in place to accommodate the electronic
receipt of registration information. This
was accomplished by including a
E:\FR\FM\02AUR1.SGM
02AUR1
]]>Agencies
[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Rules and Regulations]
[Page 45927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18967]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 774
The Commerce Control List
CFR Correction
In Title 15 of the Code of Federal Regulations, Parts 300 to 799,
revised as of January 1, 2012, in supplement no. 1 to part 774, in
Category 6, make the following corrections:
0
1. In 6A001:
0
A. On page 807, in the note following paragraph 6A001.a.1, add
``equipment as follows'' after ``6A001.a.1 does not control''.
0
B. On page 807, in paragraph a.1.a.1.a, remove ``20'' and add
``20[deg]'' in its place.
0
C. On page 810, designating the notes following 6A001.b.2 as ``Note 1''
and ``Note 2''.
0
D. On page 810, removing the note to 6A001.a.2 following the N.B. at
the end of the section.
0
2. In 6A992, on page 826, in the table for ``License Requirements'',
remove the entry for RS and place it below the table as an indented
paragraph.
0
3. In 6B108, on page 830, remove ``Unit: r'' and add ``Unit: Number''
in its place.
0
4. In 6C005, on page 831, add ``License Requirements'' above ``Reason
for Control''.
0
5. In 6D001, on page 831, remove ``CIV: * * *'' and add ``CIV: N/A'' in
its place.
0
6. In 6D003:
0
A. On page 832, in ``Reason for Control'', after ``NS'', add ``RS,''.
0
B. On page 833, remove paragraphs h.1.a and h.1.b.
0
7. In 6E001, on page 834, add ``License Requirements'' above ``Reason
for Control''.
0
8. In 6E002, on page 835, add ``License Requirements'' above ``Reason
for Control''.
[FR Doc. 2012-18967 Filed 8-1-12; 8:45 am]
BILLING CODE 1505-01-D
