Change of Addresses and Names; Technical Amendment, 13111-13114 [E9-6795]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations
organization has yet to implement a
hedge for marginal losses. Accordingly,
we decline to order hedging of marginal
losses at this time. Nevertheless, we
recognize that a marginal loss hedge
could provide benefits to certain market
participants. The Commission supports
development of a marginal loss hedging
product if its design progresses beyond
the theoretical level and it can be
developed cost-effectively.
47. The Commission also denies
SMUD’s request to exempt long-term
firm transmission customers from
marginal losses and charge them actual
or estimated system average losses. This
raises a market design issue that has
implications beyond the design of longterm firm transmission rights and is
more appropriately resolved by each
transmission organization on a case-bycase basis. Moreover, since we find that
EPAct 2005 does not address marginal
losses, this request is beyond the scope
of this rulemaking proceeding.
By the Commission.
Kimberly D. Bose,
Secretary.
[FR Doc. E9–6698 Filed 3–25–09; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 26, 201, 203, 206, 310,
312, 314, 320, and 600
[Docket No. FDA–2009–N–0133]
Change of Addresses and Names;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to reflect a change of address
for the Center for Drug Evaluation and
Research’s (CDER’s) Central Document
Room in Beltsville, MD; the relocation
of certain CDER offices to the White Oak
campus in Silver Spring, MD; and
changes of the names of certain CDER
organizational units. This action is
editorial in nature and is intended to
ensure the accuracy and clarity of the
agency’s regulations.
DATES: This rule is effective March 26,
2009.
FOR FURTHER INFORMATION CONTACT:
Wendy Aaronson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
VerDate Nov<24>2008
16:51 Mar 25, 2009
Jkt 217001
Hampshire Ave., Bldg. 22, rm. 1128,
Silver Spring, MD 20993–0002, 301–
796–0410.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulations in parts 1, 26,
201, 203, 206, 310, 312, 314, 320, and
600 (21 CFR parts 1, 26, 201, 203, 206,
310, 312, 314, 320, and 600) to reflect
the following changes: (1) Names of
certain CDER organizational units; (2) a
change of address for CDER’s Central
Document Room in Beltsville, MD; and
(3) the relocation of certain CDER offices
to the White Oak campus in Silver
Spring, MD. The addresses are locations
to which applicants must submit
information related to marketing
applications or products regulated by
CDER or from which the public can
request information. Where appropriate,
Internet addresses for obtaining
information and forms are added and
outdated addresses are removed.
The technical amendments made by
this document are largely related to
paper submissions; however, FDA is
committed to adapting its business
practices to evolving technology,
including using the significant
advancements in Web-based, electronic
systems. We anticipate that, in future
rulemakings, Web-based filing of most
submissions will eventually be required.
We anticipate that when a change to an
electronic submission system is
implemented, we will provide guidance
to address any technical questions
related to such submissions.
The technical amendments, reflected
in the regulatory text of this final rule,
are as follows:
• In § 1.101(d)(2)(ii), the address to
submit notifications for products
regulated by CDER exported under
section 802 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 382) is
changed to the White Oak campus.
• In Appendix E to subpart A of part
26, the contact information for CDER’s
Office of Compliance is updated to the
White Oak campus.
• In § 201.58, the address to submit
requests for waivers of labeling
requirements is updated to the Beltsville
Central Document Room.
• In § 203.12, the CDER address for
notification of an appeal from an
adverse decision regarding
reimportation of an insulin-containing
or prescription drug by a district office
is changed to the White Oak campus.
• In § 203.37(e), the address to submit
information regarding falsification of
drug sample records or loss or theft of
samples for prescription drugs and
biological products regulated by CDER
is changed to the White Oak campus.
• In § 203.70(b)(1), the address to
apply for a reward for providing
PO 00000
Frm 00057
Fmt 4700
Sfmt 4700
13111
information leading to a criminal
proceeding or conviction related to the
sale, purchase, or trade of a drug sample
is changed to the White Oak campus.
• In § 206.7(b)(1)(i), the address to
request exemptions from imprinting
requirements for solid oral dosage form
drugs is updated to the Beltsville
Central Document Room.
• In § 310.6(e), the address for
interested parties to submit the names of
drug products, and of their
manufacturers or distributors, that
should be subject to the same
purchasing and regulatory policies as
those reviewed by the Drug Efficacy
Study Group is changed to the White
Oak campus.
• In §§ 310.305(c) and 314.98(b), the
address to submit postmarketing safety
reports is updated to the Beltsville
Central Document Room. (Note that
applicants and any person other than
the applicant whose name appears on
the label of an approved drug product
as a manufacturer, packer, or distributor
may also elect to submit postmarketing
safety reports in electronic format.)
• In §§ 310.305(d)(4) and 314.80(f)(4),
the address to obtain reporting forms is
updated to reflect Internet availability.
• In §§ 310.501(e) and 310.515(d), the
name and address to request labeling
guidance for estrogen drug products are
updated to the Division of Reproductive
and Urologic Products and the White
Oak campus.
• In § 312.140(b), mailing instructions
are updated to ensure submissions are
addressed properly.
• In §§ 312.145(b) and 314.445(b), the
CDER unit from which to request a list
of CDER guidances is updated to the
Division of Drug Information. The
address is updated to the White Oak
campus, and an Internet address is
added to reflect the availability of the
list on the Internet.
• In § 314.80(d)(2) and (f)(3)(ii), the
CDER unit to contact regarding
alternative reporting formats is updated
to the Office of Surveillance and
Epidemiology.
• In § 314.81(b)(3)(i), the address to
obtain Form FDA–2253 (Transmittal of
Advertisements and Promotional
Labeling for Drugs for Human Use) is
updated to reflect Internet availability.
• In § 314.200(a)(3), the address to
request opinions of the applicability of
a notice of opportunity for a hearing
published in the Federal Register to a
specific product that may be identical,
related, or similar to a product listed in
the notice is changed to the White Oak
campus.
• In § 314.440(a), an outdated address
to submit applications, abbreviated
applications, and related
E:\FR\FM\26MRR1.SGM
26MRR1
13112
Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations
correspondence is removed and in
§ 314.440(a)(1), mailing instructions are
updated to ensure submissions are
addressed properly and the address to
obtain folders for binding applications
is updated to reflect information
available at an Internet address.
• In § 320.30(c)(1), the name and
address to submit general inquiries
related to bioavailability requirements
and methodology are updated to the
Office of Clinical Pharmacology and the
White Oak campus.
• In § 600.2(b)(1), the address for
submitting biological product deviation
reports for biological products regulated
by CDER is changed to the White Oak
campus.
• In § 600.2(b)(3), the address for
submitting advertising and promotional
labeling supplements required under
§ 600.12(f) is updated to the Beltsville
Central Document Room.
Publication of this document
constitutes final action on these changes
under the Administrative Procedure 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 update names and addresses
of CDER organizational units.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting
and recordkeeping requirements.
21 CFR Part 201
Drugs, Labeling, Reporting and
recordkeeping requirements.
Biologics, Reporting and
recordkeeping requirements.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 1, 26,
201, 203, 206, 310, 312, 314, 320, and
600 are amended as follows:
PART 1—GENERAL ENFORCEMENT
REGULATIONS
1. The authority citation for 21 CFR
part 1 continues to read as follows:
■
Authority: 15 U.S.C. 1453, 1454, 1455; 19
U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 333,
334, 335a, 343, 350c, 350d, 352, 355, 360b,
362, 371, 374, 381, 382, 393; 42 U.S.C. 216,
241, 243, 262, 264.
§ 1.101
[Amended]
2. Section 1.101 is amended in
paragraph (d)(2)(ii) by removing ‘‘(HFD–
310)’’; and by removing ‘‘5600 Fishers
Lane, Rockville, MD 20857’’ and adding
in its place ‘‘10903 New Hampshire
Ave., Silver Spring, MD 20993–0002’’.
■
Authority: 5 U.S.C. 552; 15 U.S.C. 1453,
1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321,
331, 351, 352, 355, 360, 360b, 360c, 360d,
360e, 360f, 360g, 360h, 360i, 360j, 360l,
360m, 371, 374, 381, 382, 383, 393; 42 U.S.C.
216, 241, 242l, 262, 264, 265.
21 CFR Part 310
Administrative practice and
procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping
requirements.
4. Appendix E to subpart A of part 26
is amended under the heading ‘‘B.
Forthe United States:’’ in the entry for
‘‘Human Drugs’’ by removing ‘‘(HFD–
300), 5600 Fishers Lane, Rockville, MD
20857, phone: 301–827–8910, fax: 301–
827–8901’’ and by adding in its place
‘‘10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, phone: 301–
796–3100, fax: 301–847–8747’’.
■
21 CFR Part 312
Drugs, Exports, Imports,
Investigations, Labeling, Medical
research, Reporting and recordkeeping
requirements, Safety.
Jkt 217001
21 CFR Part 600
3. The authority citation for 21 CFR
part 26 continues to read as follows:
21 CFR Part 206
Drugs.
16:51 Mar 25, 2009
Drugs, Reporting and recordkeeping
requirements.
■
21 CFR Part 203
Labeling, Prescription drugs,
Reporting and recordkeeping
requirements, Warehouses.
VerDate Nov<24>2008
21 CFR Part 320
PART 26—MUTUAL RECOGNITION OF
PHARMACEUTICAL GOOD
MANUFACTURING PRACTICE
REPORTS, MEDICAL DEVICE QUALITY
SYSTEM AUDIT REPORTS, AND
CERTAIN MEDICAL DEVICE PRODUCT
EVALUATION REPORTS: UNITED
STATES AND THE EUROPEAN
COMMUNITY
21 CFR Part 26
Animal drugs, Biologics, Drugs,
Exports, Imports.
21 CFR Part 314
Administrative practice and
procedure, Confidential business
information, Drugs, Reporting and
recordkeeping requirements.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 358, 360, 360b, 360gg–360ss, 371,
374, 379e; 42 U.S.C. 216, 241, 262, 264.
§ 201.58
[Amended]
6. Section 201.58 is amended in the
second sentence by removing ‘‘5600
Fishers Lane, Rockville, MD 20857’’ and
by adding in its place ‘‘Central
Document Room, 5901–B Ammendale
Rd., Beltsville, MD 20705–1266’’.
■
PART 203—PRESCRIPTION DRUG
MARKETING
7. The authority citation for 21 CFR
part 203 continues to read as follows:
■
Authority: 21 U.S.C. 331, 333, 351, 352,
353, 360, 371, 374, 381.
§ 203.12
[Amended]
8. Section 203.12 is amended by
removing ‘‘(HFD–300)’’ both times it
appears; and by removing ‘‘5600 Fishers
Lane, Rockville, MD 20857’’ both times
it appears and adding in its place
‘‘10903 New Hampshire Ave., Silver
Spring, MD 20993–0002’’.
■
§ 203.37
[Amended]
9. Section 203.37 is amended in the
first sentence of paragraph (e) by
removing ‘‘(HFD–330)’’; and by
removing ‘‘5600 Fishers Lane, Rockville,
MD 20857’’ and adding in its place
‘‘10903 New Hampshire Ave., Silver
Spring, MD 20993–0002’’.
■
§ 203.70
[Amended]
10. Section 203.70 is amended in
paragraph (b)(1) by removing ‘‘(HFD–
300)’’; and by removing ‘‘5600 Fishers
Lane, Rockville, MD 20857’’ and adding
in its place ‘‘10903 New Hampshire
Ave., Silver Spring, MD 20993–0002’’.
■
PART 206—IMPRINTING OF SOLID
ORAL DOSAGE FORM DRUG
PRODUCTS FOR HUMAN USE
11. The authority citation for 21 CFR
part 206 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 355,
371; 42 U.S.C. 262.
§ 206.7
[Amended]
12. Section 206.7 is amended in
paragraph (b)(1)(i) by removing ‘‘5600
Fishers Lane, Rockville, MD 20857’’ and
by adding in its place ‘‘5901–B
Ammendale Rd., Beltsville, MD 20705–
1266’’.
■
PART 310—NEW DRUGS
13. The authority citation for 21 CFR
part 310 continues to read as follows:
PART 201—LABELING
■
5. The authority citation for 21 CFR
part 201 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360b–360f, 360j, 361(a), 371, 374,
■
PO 00000
Frm 00058
Fmt 4700
Sfmt 4700
E:\FR\FM\26MRR1.SGM
26MRR1
Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations
375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b–263n.
§ 310.6
[Amended]
14. Section 310.6 is amended in the
first sentence of paragraph (e) by
removing ‘‘HFD–300, 5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002’’.
■ 15. Section 310.305 is amended in
paragraph (c) by removing ‘‘Division of
Pharmacovigilance and Epidemiology
(HFD–730)’’ and by adding in its place
‘‘Central Document Room’’; by removing
‘‘5600 Fishers Lane, Rockville, MD
20857’’ and by adding in its place
‘‘5901–B Ammendale Rd., Beltsville,
MD 20705–1266’’; and by revising
paragraph (d)(4) to read as follows:
■
§ 310.305 Records and reports concerning
adverse drug experiences on marketed
prescription drugs for human use without
approved new drug applications.
*
*
*
*
*
(d) * * *
(4) FDA Form 3500A and instructions
for completing the form are available on
the Internet at https://www.fda.gov/
medwatch/.
*
*
*
*
*
§ 310.501
[Amended]
16. Section 310.501 is amended in
paragraph (e) by removing ‘‘Metabolism
and Endocrine Drug Products (HFD–
510)’’ and by adding in its place
‘‘Reproductive and Urologic Products’’
and by removing ‘‘5600 Fishers Lane,
Rockville, MD 20857’’ and by adding in
its place ‘‘10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002’’.
■
§ 310.515
[Amended]
17. Section 310.515 is amended in the
second sentence of paragraph (d) by
removing ‘‘Metabolism and Endocrine
Drug Products (HFD–510)’’ and by
adding in its place ‘‘Reproductive and
Urologic Products’’ and by removing
‘‘5600 Fishers Lane, Rockville, MD
20857’’ and by adding in its place
‘‘10903 New Hampshire Ave., Silver
Spring, MD 20993–0002’’.
■
PART 312—INVESTIGATIONAL NEW
DRUG APPLICATION
18. The authority citation for 21 CFR
part 312 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 356, 371, 381, 383, 393; 42 U.S.C.
262.
§ 312.140
19. Section 312.140 is amended in the
second sentence of paragraph (b) by
removing ‘‘directed to the appropriate
■
16:51 Mar 25, 2009
§ 312.145
[Amended]
20. Section 312.145 is amended in the
third sentence of paragraph (b) by
removing ‘‘Division of Communications
Management, Drug Information Branch
(HFD–210)’’ and by adding in its place
‘‘Division of Drug Information’’ and by
removing ‘‘5600 Fishers Lane, Rockville,
MD 20857’’ and by adding in its place
‘‘10903 New Hampshire Ave., Silver
Spring, MD 20993–0002’’.
■
PART 314—APPLICATIONS FOR FDA
APPROVAL TO MARKET A NEW DRUG
21. The authority citation for 21 CFR
part 314 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 356, 356a, 356b, 356c, 371, 374,
379e.
22. Section 314.80 is amended as
follows:
■ a. In the second sentence of paragraph
(d)(2), by removing ‘‘Division of
Pharmacovigilance and Epidemiology’’
and by adding in its place ‘‘Office of
Surveillance and Epidemiology’’; and
■ b. By revising paragraphs (f)(3)(ii) and
(f)(4) to read as follows:
The revisions read as follows:
■
§ 314.80 Postmarketing reporting of
adverse drug experiences.
*
*
*
*
*
(f) * * *
(3) * * * (ii) The format is agreed to
in advance by the Office of Surveillance
and Epidemiology.
(4) FDA Form 3500A and instructions
for completing the form are available on
the Internet at https://www.fda.gov/
medwatch/.
*
*
*
*
*
■ 23. Section 314.81 is amended by
revising the last sentence of paragraph
(b)(3)(i) to read as follows:
§ 314.81
Other postmarketing reports.
*
*
*
*
*
(b) * * *
(3) * * *
(i) * * *Form FDA–2253 is available
on the Internet at https://www.fda.gov/
opacom/morechoices/fdaforms/
cder.html.
*
*
*
*
*
§ 314.98
[Amended]
24. Section 314.98 is amended in
paragraph (b) by removing ‘‘Division of
Epidemiology and Surveillance (HFD–
730)’’ and by adding in its place
‘‘Central Document Room’’ and by
■
[Amended]
VerDate Nov<24>2008
Center and division’’ and by adding in
its place ‘‘sent to the appropriate center
at the address indicated in this section
and marked to the attention of the
responsible division’’.
Jkt 217001
PO 00000
Frm 00059
Fmt 4700
Sfmt 4700
13113
removing ‘‘5600 Fishers Lane, Rockville,
MD 20857’’ and by adding in its place
‘‘5901–B Ammendale Rd., Beltsville,
MD 20705–1266’’.
§ 314.200
[Amended]
25. Section 314.200 is amended in the
second sentence of paragraph (a)(3) by
removing ‘‘(HFD–310)’’; and by
removing ‘‘5600 Fishers Lane, Rockville,
MD 20857’’ and adding in its place
‘‘10903 New Hampshire Ave., Silver
Spring, MD 20993–0002’’.
■
26. Section 314.440 is amended by
revising paragraph (a) introductory text,
and paragraph (a)(1) to read as follows:
■
§ 314.440 Addresses for applications and
abbreviated applications.
(a) Applicants shall send applications,
abbreviated applications, and other
correspondence relating to matters
covered by this part, except for products
listed in paragraph (b) of this section, to
the appropriate office identified below:
(1) Except as provided in paragraph
(a)(4) of this section, an application
under § 314.50 or § 314.54 submitted for
filing should be directed to the Central
Document Room, 5901–B Ammendale
Rd., Beltsville, MD 20705–1266.
Applicants may obtain information
about folders for binding applications
on the Internet at https://www.fda.gov/
cder/ddms/binders.htm. After FDA has
filed the application, the agency will
inform the applicant which division is
responsible for the application.
Amendments, supplements,
resubmissions, requests for waivers, and
other correspondence about an
application that has been filed should
be addressed to 5901–B Ammendale
Rd., Beltsville, MD 20705–1266, to the
attention of the appropriate division.
*
*
*
*
*
§ 314.445
[Amended]
27. Section 314.445 is amended in the
third sentence of paragraph (b) by
removing ‘‘Division of Communications
Management, Drug Information Branch
(HFD–210)’’ and by adding in its place
‘‘Division of Drug Information’’ and by
removing ‘‘5600 Fishers Lane, Rockville,
MD 20857’’ and by adding in its place
‘‘10903 New Hampshire Ave., Silver
Spring, MD 20993–0002’’.
■
PART 320—BIOAVAILABILITY AND
BIOEQUIVALENCE REQUIREMENTS
28. The authority citation for 21 CFR
part 320 continues to read as follows:
■
Authority: 21 U.S.C. 321, 351, 352, 355,
371.
E:\FR\FM\26MRR1.SGM
26MRR1
13114
§ 320.30
Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations
[Amended]
29. Section 320.30 is amended in
paragraph (c)(1) by removing ‘‘and
Biopharmaceutics (HFD–850), 5600
Fishers Lane, Rockville, MD 20857’’ and
by adding in its place ‘‘, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002’’.
■
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 101
[Docket Nos. TSA–2006–24191; USCG–
2006–24196]
RIN 1652–AA41
PART 600—BIOLOGICAL PRODUCTS:
GENERAL
30. The authority citation for 21 CFR
part 600 continues to read as follows:
■
Authority: 21 U.S.C. 321, 351, 352, 355,
360, 360i, 371, 374; 42 U.S.C. 216, 262, 263,
263a, 264, 300aa–25.
§ 600.2
[Amended]
31. Section 600.2 is amended as
follows:
a. In paragraph (b)(1) by removing
‘‘(HFD–330)’’; and by removing ‘‘5600
Fishers Lane, Rockville, MD 20857’’ and
adding in its place ‘‘10903 New
Hampshire Ave., Silver Spring, MD
20993–0002’’; and
b. In paragraph (b)(3) by removing
‘‘(HFD–42)’’; and by removing ‘‘5600
Fishers Lane, rm. 8B45, Rockville, MD
20857’’ and adding in its place ‘‘5901–
B Ammendale Rd., Beltsville, MD
20705–1266’’.
■
Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–6795 Filed 3–25–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds
CFR Correction
In title 21 of the Code of Federal
Regulations, part 558, revised as of
April 1, 2008, on page 410, in § 558.58
(e)(1)(iii), the entry for Bambermycins 1
to 3, in the column under ‘‘Limitations’’
remove ‘‘057926’’ and in its place add
‘‘016592’’; in the column under
‘‘Sponsors’’, add ‘‘016592’’.
[FR Doc. E9–6810 Filed 3–25–09; 8:45 am]
BILLING CODE 1505–01–D
VerDate Nov<24>2008
16:51 Mar 25, 2009
Jkt 217001
Transportation Worker Identification
Credential (TWIC) Implementation in
the Maritime Sector; Hazardous
Materials Endorsement for a
Commercial Driver’s License
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department of Homeland
Security (DHS) through the United
States Coast Guard (Coast Guard) issues
this final rule to amend one provision
of its previously issued final rule.
Specifically, the Coast Guard is
amending its definition of secure area to
take into account facilities in American
Samoa, whose workers are not required
to be authorized to work in the United
States under U.S. immigration law when
working in American Samoa.
DATES: This final rule is effective March
26, 2009.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of dockets TSA–2006–24191 and
USCG–2006–24196, and are available
for inspection or copying at the Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. You may also
find this docket on the Internet by going
to https://www.regulations.gov, selecting
the Advanced Docket Search option on
the right side of the screen, inserting
TSA–2006–24191 or USCG–2006–24196
in the Docket ID box, pressing Enter,
and then clicking on the item in the
Docket ID column.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call
LCDR Jonathan Maiorine, Coast Guard;
telephone 1–877–687–2243. If you have
questions on viewing the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
I. Regulatory History
On May 22, 2006, the Department of
Homeland Security (DHS), through the
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
United States Coast Guard (Coast Guard)
and the Transportation Security
Administration (TSA), published a joint
notice of proposed rulemaking entitled
‘‘Transportation Worker Identification
Credential (TWIC) Implementation in
the Maritime Sector; Hazardous
Materials Endorsement for a
Commercial Driver’s License’’ in the
Federal Register (71 FR 29396). This
was followed by a 45-day comment
period and four public meetings. The
Coast Guard and TSA issued a joint
final rule, under the same title, on
January 25, 2007 (72 FR 3492)
(hereinafter referred to as the original
TWIC final rule). The preamble to that
final rule contains a discussion of the
provisions found in the original TWIC
final rule, which became effective on
March 26, 2007.
On September 28, 2007, the Coast
Guard and TSA issued a joint final rule
(72 FR 55043) that, among other things,
revised the definition for ‘‘secure area’’
to account for facilities in the
Commonwealth of the Northern Mariana
Islands (the CNMI), as non-citizen
workers at those facilities are not
required to have authorization to work
in the United States under U.S.
immigration law before being allowed to
work.
On May 7, 2008, the Coast Guard and
TSA issued a joint final rule to realign
the compliance date for implementation
of the original TWIC final rule (see 73
FR 25562). The date by which mariners
need to obtain a TWIC, and by which
owners and operators of vessels and
outer continental shelf facilities must
implement access control procedures
using TWIC, is April 15, 2009. Owners
and operators of facilities that must
comply with 33 CFR part 105 are subject
to earlier, rolling compliance dates, as
set forth in 33 CFR 105.115(e). The
Coast Guard announced these rolling
compliance dates via notices published
in the Federal Register. The final
compliance date for all COTP Zones is
not later than April 15, 2009.
On September 30, 2008, the Coast
Guard announced the compliance date
for COTP Zone Honolulu would be
February 12, 2009 (73 FR 56730). On
February 12, 2009, the Coast Guard
announced the extension of that
compliance date, for the territory of
American Samoa only, to April 14,
2009, due to the fact that a large
percentage of the maritime workforce is
not native to the island, and does not
need to be authorized to work in the
United States under U.S. immigration
law before being allowed to work in
American Samoa. In that notice, the
Coast Guard stated that the extension
was being granted in order to allow time
E:\FR\FM\26MRR1.SGM
26MRR1
]]>Agencies
[Federal Register Volume 74, Number 57 (Thursday, March 26, 2009)]
[Rules and Regulations]
[Pages 13111-13114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6795]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 26, 201, 203, 206, 310, 312, 314, 320, and 600
[Docket No. FDA-2009-N-0133]
Change of Addresses and Names; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to reflect a change of address for the Center for Drug
Evaluation and Research's (CDER's) Central Document Room in Beltsville,
MD; the relocation of certain CDER offices to the White Oak campus in
Silver Spring, MD; and changes of the names of certain CDER
organizational units. This action is editorial in nature and is
intended to ensure the accuracy and clarity of the agency's
regulations.
DATES: This rule is effective March 26, 2009.
FOR FURTHER INFORMATION CONTACT: Wendy Aaronson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 1128, Silver Spring, MD 20993-0002, 301-
796-0410.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts 1,
26, 201, 203, 206, 310, 312, 314, 320, and 600 (21 CFR parts 1, 26,
201, 203, 206, 310, 312, 314, 320, and 600) to reflect the following
changes: (1) Names of certain CDER organizational units; (2) a change
of address for CDER's Central Document Room in Beltsville, MD; and (3)
the relocation of certain CDER offices to the White Oak campus in
Silver Spring, MD. The addresses are locations to which applicants must
submit information related to marketing applications or products
regulated by CDER or from which the public can request information.
Where appropriate, Internet addresses for obtaining information and
forms are added and outdated addresses are removed.
The technical amendments made by this document are largely related
to paper submissions; however, FDA is committed to adapting its
business practices to evolving technology, including using the
significant advancements in Web-based, electronic systems. We
anticipate that, in future rulemakings, Web-based filing of most
submissions will eventually be required. We anticipate that when a
change to an electronic submission system is implemented, we will
provide guidance to address any technical questions related to such
submissions.
The technical amendments, reflected in the regulatory text of this
final rule, are as follows:
In Sec. 1.101(d)(2)(ii), the address to submit
notifications for products regulated by CDER exported under section 802
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 382) is changed
to the White Oak campus.
In Appendix E to subpart A of part 26, the contact
information for CDER's Office of Compliance is updated to the White Oak
campus.
In Sec. 201.58, the address to submit requests for
waivers of labeling requirements is updated to the Beltsville Central
Document Room.
In Sec. 203.12, the CDER address for notification of an
appeal from an adverse decision regarding reimportation of an insulin-
containing or prescription drug by a district office is changed to the
White Oak campus.
In Sec. 203.37(e), the address to submit information
regarding falsification of drug sample records or loss or theft of
samples for prescription drugs and biological products regulated by
CDER is changed to the White Oak campus.
In Sec. 203.70(b)(1), the address to apply for a reward
for providing information leading to a criminal proceeding or
conviction related to the sale, purchase, or trade of a drug sample is
changed to the White Oak campus.
In Sec. 206.7(b)(1)(i), the address to request exemptions
from imprinting requirements for solid oral dosage form drugs is
updated to the Beltsville Central Document Room.
In Sec. 310.6(e), the address for interested parties to
submit the names of drug products, and of their manufacturers or
distributors, that should be subject to the same purchasing and
regulatory policies as those reviewed by the Drug Efficacy Study Group
is changed to the White Oak campus.
In Sec. Sec. 310.305(c) and 314.98(b), the address to
submit postmarketing safety reports is updated to the Beltsville
Central Document Room. (Note that applicants and any person other than
the applicant whose name appears on the label of an approved drug
product as a manufacturer, packer, or distributor may also elect to
submit postmarketing safety reports in electronic format.)
In Sec. Sec. 310.305(d)(4) and 314.80(f)(4), the address
to obtain reporting forms is updated to reflect Internet availability.
In Sec. Sec. 310.501(e) and 310.515(d), the name and
address to request labeling guidance for estrogen drug products are
updated to the Division of Reproductive and Urologic Products and the
White Oak campus.
In Sec. 312.140(b), mailing instructions are updated to
ensure submissions are addressed properly.
In Sec. Sec. 312.145(b) and 314.445(b), the CDER unit
from which to request a list of CDER guidances is updated to the
Division of Drug Information. The address is updated to the White Oak
campus, and an Internet address is added to reflect the availability of
the list on the Internet.
In Sec. 314.80(d)(2) and (f)(3)(ii), the CDER unit to
contact regarding alternative reporting formats is updated to the
Office of Surveillance and Epidemiology.
In Sec. 314.81(b)(3)(i), the address to obtain Form FDA-
2253 (Transmittal of Advertisements and Promotional Labeling for Drugs
for Human Use) is updated to reflect Internet availability.
In Sec. 314.200(a)(3), the address to request opinions of
the applicability of a notice of opportunity for a hearing published in
the Federal Register to a specific product that may be identical,
related, or similar to a product listed in the notice is changed to the
White Oak campus.
In Sec. 314.440(a), an outdated address to submit
applications, abbreviated applications, and related
[[Page 13112]]
correspondence is removed and in Sec. 314.440(a)(1), mailing
instructions are updated to ensure submissions are addressed properly
and the address to obtain folders for binding applications is updated
to reflect information available at an Internet address.
In Sec. 320.30(c)(1), the name and address to submit
general inquiries related to bioavailability requirements and
methodology are updated to the Office of Clinical Pharmacology and the
White Oak campus.
In Sec. 600.2(b)(1), the address for submitting
biological product deviation reports for biological products regulated
by CDER is changed to the White Oak campus.
In Sec. 600.2(b)(3), the address for submitting
advertising and promotional labeling supplements required under Sec.
600.12(f) is updated to the Beltsville Central Document Room.
Publication of this document constitutes final action on these
changes under the Administrative Procedure 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 update
names and addresses of CDER organizational units.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 26
Animal drugs, Biologics, Drugs, Exports, Imports.
21 CFR Part 201
Drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 203
Labeling, Prescription drugs, Reporting and recordkeeping
requirements, Warehouses.
21 CFR Part 206
Drugs.
21 CFR Part 310
Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.
21 CFR Part 314
Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.
21 CFR Part 320
Drugs, Reporting and recordkeeping requirements.
21 CFR Part 600
Biologics, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1, 26, 201, 203, 206, 310, 312, 314, 320, and 600 are amended as
follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for 21 CFR part 1 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b,
362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.
Sec. 1.101 [Amended]
0
2. Section 1.101 is amended in paragraph (d)(2)(ii) by removing ``(HFD-
310)''; and by removing ``5600 Fishers Lane, Rockville, MD 20857'' and
adding in its place ``10903 New Hampshire Ave., Silver Spring, MD
20993-0002''.
PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING
PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND
CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES
AND THE EUROPEAN COMMUNITY
0
3. The authority citation for 21 CFR part 26 continues to read as
follows:
Authority: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C.
1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d,
360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382,
383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.
0
4. Appendix E to subpart A of part 26 is amended under the heading ``B.
Forthe United States:'' in the entry for ``Human Drugs'' by removing
``(HFD-300), 5600 Fishers Lane, Rockville, MD 20857, phone: 301-827-
8910, fax: 301-827-8901'' and by adding in its place ``10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, phone: 301-796-3100, fax:
301-847-8747''.
PART 201--LABELING
0
5. The authority citation for 21 CFR part 201 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
Sec. 201.58 [Amended]
0
6. Section 201.58 is amended in the second sentence by removing ``5600
Fishers Lane, Rockville, MD 20857'' and by adding in its place
``Central Document Room, 5901-B Ammendale Rd., Beltsville, MD 20705-
1266''.
PART 203--PRESCRIPTION DRUG MARKETING
0
7. The authority citation for 21 CFR part 203 continues to read as
follows:
Authority: 21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374,
381.
Sec. 203.12 [Amended]
0
8. Section 203.12 is amended by removing ``(HFD-300)'' both times it
appears; and by removing ``5600 Fishers Lane, Rockville, MD 20857''
both times it appears and adding in its place ``10903 New Hampshire
Ave., Silver Spring, MD 20993-0002''.
Sec. 203.37 [Amended]
0
9. Section 203.37 is amended in the first sentence of paragraph (e) by
removing ``(HFD-330)''; and by removing ``5600 Fishers Lane, Rockville,
MD 20857'' and adding in its place ``10903 New Hampshire Ave., Silver
Spring, MD 20993-0002''.
Sec. 203.70 [Amended]
0
10. Section 203.70 is amended in paragraph (b)(1) by removing ``(HFD-
300)''; and by removing ``5600 Fishers Lane, Rockville, MD 20857'' and
adding in its place ``10903 New Hampshire Ave., Silver Spring, MD
20993-0002''.
PART 206--IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR
HUMAN USE
0
11. The authority citation for 21 CFR part 206 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 355, 371; 42 U.S.C. 262.
Sec. 206.7 [Amended]
0
12. Section 206.7 is amended in paragraph (b)(1)(i) by removing ``5600
Fishers Lane, Rockville, MD 20857'' and by adding in its place ``5901-B
Ammendale Rd., Beltsville, MD 20705-1266''.
PART 310--NEW DRUGS
0
13. The authority citation for 21 CFR part 310 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374,
[[Page 13113]]
375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n.
Sec. 310.6 [Amended]
0
14. Section 310.6 is amended in the first sentence of paragraph (e) by
removing ``HFD-300, 5600 Fishers Lane, Rockville, MD 20857'' and by
adding in its place ``10903 New Hampshire Ave., Silver Spring, MD
20993-0002''.
0
15. Section 310.305 is amended in paragraph (c) by removing ``Division
of Pharmacovigilance and Epidemiology (HFD-730)'' and by adding in its
place ``Central Document Room''; by removing ``5600 Fishers Lane,
Rockville, MD 20857'' and by adding in its place ``5901-B Ammendale
Rd., Beltsville, MD 20705-1266''; and by revising paragraph (d)(4) to
read as follows:
Sec. 310.305 Records and reports concerning adverse drug experiences
on marketed prescription drugs for human use without approved new drug
applications.
* * * * *
(d) * * *
(4) FDA Form 3500A and instructions for completing the form are
available on the Internet at https://www.fda.gov/medwatch/.
* * * * *
Sec. 310.501 [Amended]
0
16. Section 310.501 is amended in paragraph (e) by removing
``Metabolism and Endocrine Drug Products (HFD-510)'' and by adding in
its place ``Reproductive and Urologic Products'' and by removing ``5600
Fishers Lane, Rockville, MD 20857'' and by adding in its place ``10903
New Hampshire Ave., Silver Spring, MD 20993-0002''.
Sec. 310.515 [Amended]
0
17. Section 310.515 is amended in the second sentence of paragraph (d)
by removing ``Metabolism and Endocrine Drug Products (HFD-510)'' and by
adding in its place ``Reproductive and Urologic Products'' and by
removing ``5600 Fishers Lane, Rockville, MD 20857'' and by adding in
its place ``10903 New Hampshire Ave., Silver Spring, MD 20993-0002''.
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
0
18. The authority citation for 21 CFR part 312 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 371,
381, 383, 393; 42 U.S.C. 262.
Sec. 312.140 [Amended]
0
19. Section 312.140 is amended in the second sentence of paragraph (b)
by removing ``directed to the appropriate Center and division'' and by
adding in its place ``sent to the appropriate center at the address
indicated in this section and marked to the attention of the
responsible division''.
Sec. 312.145 [Amended]
0
20. Section 312.145 is amended in the third sentence of paragraph (b)
by removing ``Division of Communications Management, Drug Information
Branch (HFD-210)'' and by adding in its place ``Division of Drug
Information'' and by removing ``5600 Fishers Lane, Rockville, MD
20857'' and by adding in its place ``10903 New Hampshire Ave., Silver
Spring, MD 20993-0002''.
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
0
21. The authority citation for 21 CFR part 314 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a,
356b, 356c, 371, 374, 379e.
0
22. Section 314.80 is amended as follows:
0
a. In the second sentence of paragraph (d)(2), by removing ``Division
of Pharmacovigilance and Epidemiology'' and by adding in its place
``Office of Surveillance and Epidemiology''; and
0
b. By revising paragraphs (f)(3)(ii) and (f)(4) to read as follows:
The revisions read as follows:
Sec. 314.80 Postmarketing reporting of adverse drug experiences.
* * * * *
(f) * * *
(3) * * * (ii) The format is agreed to in advance by the Office of
Surveillance and Epidemiology.
(4) FDA Form 3500A and instructions for completing the form are
available on the Internet at https://www.fda.gov/medwatch/.
* * * * *
0
23. Section 314.81 is amended by revising the last sentence of
paragraph (b)(3)(i) to read as follows:
Sec. 314.81 Other postmarketing reports.
* * * * *
(b) * * *
(3) * * *
(i) * * *Form FDA-2253 is available on the Internet at https://www.fda.gov/opacom/morechoices/fdaforms/cder.html.
* * * * *
Sec. 314.98 [Amended]
0
24. Section 314.98 is amended in paragraph (b) by removing ``Division
of Epidemiology and Surveillance (HFD-730)'' and by adding in its place
``Central Document Room'' and by removing ``5600 Fishers Lane,
Rockville, MD 20857'' and by adding in its place ``5901-B Ammendale
Rd., Beltsville, MD 20705-1266''.
Sec. 314.200 [Amended]
0
25. Section 314.200 is amended in the second sentence of paragraph
(a)(3) by removing ``(HFD-310)''; and by removing ``5600 Fishers Lane,
Rockville, MD 20857'' and adding in its place ``10903 New Hampshire
Ave., Silver Spring, MD 20993-0002''.
0
26. Section 314.440 is amended by revising paragraph (a) introductory
text, and paragraph (a)(1) to read as follows:
Sec. 314.440 Addresses for applications and abbreviated applications.
(a) Applicants shall send applications, abbreviated applications,
and other correspondence relating to matters covered by this part,
except for products listed in paragraph (b) of this section, to the
appropriate office identified below:
(1) Except as provided in paragraph (a)(4) of this section, an
application under Sec. 314.50 or Sec. 314.54 submitted for filing
should be directed to the Central Document Room, 5901-B Ammendale Rd.,
Beltsville, MD 20705-1266. Applicants may obtain information about
folders for binding applications on the Internet at https://www.fda.gov/cder/ddms/binders.htm. After FDA has filed the application, the agency
will inform the applicant which division is responsible for the
application. Amendments, supplements, resubmissions, requests for
waivers, and other correspondence about an application that has been
filed should be addressed to 5901-B Ammendale Rd., Beltsville, MD
20705-1266, to the attention of the appropriate division.
* * * * *
Sec. 314.445 [Amended]
0
27. Section 314.445 is amended in the third sentence of paragraph (b)
by removing ``Division of Communications Management, Drug Information
Branch (HFD-210)'' and by adding in its place ``Division of Drug
Information'' and by removing ``5600 Fishers Lane, Rockville, MD
20857'' and by adding in its place ``10903 New Hampshire Ave., Silver
Spring, MD 20993-0002''.
PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
0
28. The authority citation for 21 CFR part 320 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 355, 371.
[[Page 13114]]
Sec. 320.30 [Amended]
0
29. Section 320.30 is amended in paragraph (c)(1) by removing ``and
Biopharmaceutics (HFD-850), 5600 Fishers Lane, Rockville, MD 20857''
and by adding in its place ``, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002''.
PART 600--BIOLOGICAL PRODUCTS: GENERAL
0
30. The authority citation for 21 CFR part 600 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 355, 360, 360i, 371, 374; 42
U.S.C. 216, 262, 263, 263a, 264, 300aa-25.
Sec. 600.2 [Amended]
0
31. Section 600.2 is amended as follows:
a. In paragraph (b)(1) by removing ``(HFD-330)''; and by removing
``5600 Fishers Lane, Rockville, MD 20857'' and adding in its place
``10903 New Hampshire Ave., Silver Spring, MD 20993-0002''; and
b. In paragraph (b)(3) by removing ``(HFD-42)''; and by removing
``5600 Fishers Lane, rm. 8B45, Rockville, MD 20857'' and adding in its
place ``5901-B Ammendale Rd., Beltsville, MD 20705-1266''.
Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6795 Filed 3-25-09; 8:45 am]
BILLING CODE 4160-01-S
