Agency Information Collection Activities: Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 48656-48658 [E7-16795]
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48656
Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0601. The
approval expires on May 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets. The standards can be
viewed on the Internet at https://
www.fda.gov/ohrms/dockets/dockets/
06d0246/06d-0246-gdl0002-vol1.pdf.
Dated: August 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–16708 Filed 8–23–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0323]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
Food and Drug Administration,
HHS.
yshivers on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
requirements governing the registration
of producers of drugs and listing of
drugs in commercial distribution.
DATES: Submit written or electronic
comments on the collection of
information by October 23, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments or https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
VerDate Aug<31>2005
14:35 Aug 23, 2007
Jkt 211001
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA 250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution—21 CFR Part 207 (OMB
Control Number 0910–0045—Extension)
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (the act),
(21 U.S.C. 360), FDA is authorized to
establish a system for registration of
producers of drugs and for listing of
drugs in commercial distribution. To
implement section 510 of the act, FDA
issued part 207 (21 CFR part 207).
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Under current1 21 CFR 207.20,
manufacturers, repackers, and relabelers
that engage in the manufacture,
preparation, propagation, compounding,
or processing of human or veterinary
drugs and biological products, including
bulk drug substances and bulk drug
substances for prescription
compounding, and drug premixes as
well as finished dosage forms, whether
prescription or over-the-counter, are
required to register their establishment.
In addition, manufacturers, repackers,
and relabelers are required to submit a
listing of every drug or biological
product in commercial distribution.
Owners or operators of establishments
that distribute, under their own label or
trade name, a drug product
manufactured by a registered
establishment are not required either to
register or list. However, distributors
may elect to submit drug listing
information in lieu of the registered
establishment that manufactures the
drug product. Foreign drug
establishments must also comply with
the establishment registration and
product listing requirements if they
import or offer for import their products
into the United States.
Under current §§ 207.21 and 207.22,
establishments, both domestic and
foreign, must register with FDA by
submitting Form FDA–2656
(Registration of Drug Establishment)
within 5 days after beginning the
manufacture of drugs or biologicals, or
within 5 days after the submission of a
drug application or biological license
application. In addition, establishments
must register annually by returning,
within 30 days of receipt from FDA,
Form FDA–2656e (Annual Update of
Drug Establishment) (Note: This form is
no longer mailed to registrants by FDA;
updating registration information is
estimated in table 1 of this document by
the information submitted annually on
Form FDA–2656). Changes in individual
ownership, corporate or partnership
1This notice requests comments on the
information collection in current part 207. In the
Federal Register of Augst 29, 2006 (71 FR 51276),
FDA proposed to revise part 207. The proposed
revisions would reorganize, consolidate, clarify,
and modify current regulations concerning who
must register establishments and list, and describes
when and how to register and list and what
information must be submitted for registration and
listing. In addition, the proposal would make
certain changes to the National Drug Code (NDC)
system and would require the appropriate NDC
number to appear on the labels for drugs subject to
the listing requirements. The proposed regulations
generally also require the electronic submission of
all registration and most listing information. The
August 29, 2006, proposed rule requested
comments on the information collection for revised
part 207. When the proposal is finalized, the
information collection for revised part 207 will
replace the information collection in this notice.
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Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices
structure, location, or drug-handling
activity must be submitted as
amendments to registration under
current § 207.26 within 5 days of such
changes. Distributors that elect to
submit drug listing information must
submit a Form FDA–2656 to FDA and
a copy of the completed form to the
registered establishment that
manufactured the product to obtain a
labeler code. Establishments must,
within 5 days of beginning the
manufacture of drugs or biologicals,
submit to FDA a listing for every drug
or biological product in commercial
distribution at that time by using Form
FDA–2657 (Drug Product Listing).
Private label distributors may elect to
submit to FDA a listing of every drug
product they place in commercial
distribution. Registered establishments
must submit to FDA drug product
listing for those private label
distributors who do not elect to submit
listing information by using Form FDA–
2658 (Registered Establishments’ Report
of Private Label Distributors).
Under current § 207.25, product
listing information submitted to FDA by
domestic and foreign manufacturers
must, depending on the type of product
being listed, include any new drug
application number or biological
establishment license number, copies of
current labeling and a sampling of
advertisements, a quantitative listing of
the active ingredient for each drug or
biological product not subject to an
approved application or license, the
National Drug Code number, and any
drug imprinting information.
In addition to the product listing
information required on Form FDA–
2657, FDA may also require, under
current § 207.31, a copy of all
advertisements and a quantitative listing
of all ingredients for each listed drug or
biological product not subject to an
approved application or license; the
basis for a determination, by the
establishment, that a listed drug or
biological product is not subject to
marketing or licensing approval
requirements; and a list of certain drugs
or biological products containing a
particular ingredient. FDA may also
request, but not require, the submission
of a qualitative listing of the inactive
ingredients for all listed drugs or
biological products, and a quantitative
listing of the active ingredients for all
listed drugs or biological products
subject to an approved application or
license.
Under current § 207.30,
establishments must update their
product listing information by using
Form FDA–2657 and/or Form FDA–
2658 every June and December or, at the
discretion of the establishment, when
any change occurs. These updates must
include the following information: (1) A
listing of all drug or biological products
introduced for commercial distribution
that have not been included in any
previously submitted list; (2) all drug or
biological products formerly listed for
which commercial distribution has been
discontinued; (3) all drug or biological
products for which a notice of
discontinuance was submitted and for
which commercial distribution has been
resumed; and (4) any material change in
any information previously submitted.
No update is required if no changes
have occurred since the previously
submitted list.
FDA estimates the annual information
collection burden for current part 207 as
follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
responses per respondent
No. of
respondents
Form
Total annual
responses
Hours per
response
Total hours
(1) Form FDA–2656 - Registration of
Drug Establishment (New registrations, including new labeler codes
for private label distributors)
39
14.72
574
2.50
1,435
(2) Form FDA–2656 - Annual Update
of Drug Establishment (Update of
registration information)
3,256
2.99
9,763
2.50
24,407.50
(3) Form FDA–2657 - Drug Product
Listing (New drug listings)
1,567
6.57
10,301
2.50
25,752.50
(4) Form FDA–2658 - Registered Establishments’ Report of Private
Label Distributors (New listings for
private label distributor drugs)
146
10.06
1,469
2.50
3,672.50
(5) Form FDA–2657 and Form FDA–
2658 - (June and December updates of all listing information)
1,677
11.21
18,797
2.50
46,992.50
yshivers on PROD1PC66 with NOTICES
Total
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102,260
14:35 Aug 23, 2007
Jkt 211001
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48658
Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices
Dated: August 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–16795 Filed 8–23–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M–0244 and 2007M–0263]
Medical Devices Regulated by the
Center for Biologics Evaluation and
Research; Availability of Summaries of
Safety and Effectiveness Data for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved by the
Center for Biologics Evaluation and
Research (CBER). This list is intended to
inform the public of the availability
through the Internet and FDA’s Division
of Dockets Management of summaries of
safety and effectiveness data of
approved PMAs.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please include the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness data.
FOR FURTHER INFORMATION CONTACT:
Nathaniel L. Geary, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, suite
200N, 1401 Rockville Pike, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register,
providing instead to post this
information on the Internet at https://
www.fda.gov. In addition, the
regulations provide that FDA publish a
quarterly list of available safety and
effectiveness summaries of PMA
approvals and denials that were
announced during the quarter. FDA
believes that this procedure expedites
public notification of these actions
because announcements can be placed
on the Internet more quickly than they
can be published in the Federal
Register, and FDA believes that the
Internet is accessible to more people
than the Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
administrative reconsideration of an
FDA action under § 10.33(b) (21 CFR
10.33(b)) for notices announcing
approval of a PMA begins on the day the
notice is placed on the Internet. Section
10.33(b) provides that FDA may, for
good cause, extend this 30-day period.
Reconsideration of a denial or
withdrawal of approval of a PMA may
be sought only by the applicant; in these
cases, the 30-day period will begin
when the applicant is notified by FDA
in writing of its decision.
The following is a list of PMAs
approved by CBER for which summaries
of safety and effectiveness data were
placed on the Internet from April 1,
2007, through June 30, 2007. There were
no denial actions during this period.
The list provides the manufacturer’s
name, the product’s generic name or the
trade name, and the approval date.
TABLE 1.—LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE APRIL 1,
2007, THROUGH JUNE 30, 2007
PMA No./Docket No.
Applicant
Trade name
BP060002/0/2007M–0244
Abbott Molecular, Inc.
Abbott RealTime HIV–1 Amplification Reagent Kit, Abbott RealTime
HIV–1 Calibrator Kit, and Abbott RealTime HIV–1 Control Kit
May 11, 2007
BP050069/0/2007M–0263
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqmanHIV–1 Test, 48 Tests, COBAS
Ampliprep/COBAS Taqman Wash Reagent, 5.1.L
May 11, 2007
II. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cber/products.htm.
Food and Drug Administration
Dated: August 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–16706 Filed 8–23–07; 8:45 am]
yshivers on PROD1PC66 with NOTICES
BILLING CODE 4160–01–S
[Docket No. 1999D–1878 (formerly Docket
No. 99D–1878)]
‘‘Guidance for Industry: ‘Lookback’ for
Hepatitis C Virus (HCV): Product
Quarantine, Consignee Notification,
Further Testing, Product Disposition,
and Notification of Transfusion
Recipients Based on Donor Test
Results Indicating Infection with HCV;’’
Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
14:35 Aug 23, 2007
Jkt 211001
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Sfmt 4703
Approval date
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: ‘Lookback’ for
Hepatitis C Virus (HCV): Product
Quarantine, Consignee Notification,
Further Testing, Product Disposition,
and Notification of Transfusion
Recipients Based on Donor Test Results
Indicating Infection with HCV,’’ dated
August 2007. The guidance document
provides recommendations for
complying with the HCV ‘‘Lookback’’
requirements. This guidance document
finalizes the guidance entitled, ‘‘Draft
Guidance for Industry: Current Good
Manufacturing Practice for Blood and
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48656-48658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0323]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Registration of Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements governing the
registration of producers of drugs and listing of drugs in commercial
distribution.
DATES: Submit written or electronic comments on the collection of
information by October 23, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments or https://www.regulations.gov.
Submit written comments on the collection of information to the
Division of Dockets Management (HFA 305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA 250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--21 CFR Part 207 (OMB Control Number 0910-0045--Extension)
Under section 510 of the Federal Food, Drug, and Cosmetic Act (the
act), (21 U.S.C. 360), FDA is authorized to establish a system for
registration of producers of drugs and for listing of drugs in
commercial distribution. To implement section 510 of the act, FDA
issued part 207 (21 CFR part 207). Under current\1\ 21 CFR 207.20,
manufacturers, repackers, and relabelers that engage in the
manufacture, preparation, propagation, compounding, or processing of
human or veterinary drugs and biological products, including bulk drug
substances and bulk drug substances for prescription compounding, and
drug premixes as well as finished dosage forms, whether prescription or
over-the-counter, are required to register their establishment. In
addition, manufacturers, repackers, and relabelers are required to
submit a listing of every drug or biological product in commercial
distribution. Owners or operators of establishments that distribute,
under their own label or trade name, a drug product manufactured by a
registered establishment are not required either to register or list.
However, distributors may elect to submit drug listing information in
lieu of the registered establishment that manufactures the drug
product. Foreign drug establishments must also comply with the
establishment registration and product listing requirements if they
import or offer for import their products into the United States.
---------------------------------------------------------------------------
\1\This notice requests comments on the information collection
in current part 207. In the Federal Register of Augst 29, 2006 (71
FR 51276), FDA proposed to revise part 207. The proposed revisions
would reorganize, consolidate, clarify, and modify current
regulations concerning who must register establishments and list,
and describes when and how to register and list and what information
must be submitted for registration and listing. In addition, the
proposal would make certain changes to the National Drug Code (NDC)
system and would require the appropriate NDC number to appear on the
labels for drugs subject to the listing requirements. The proposed
regulations generally also require the electronic submission of all
registration and most listing information. The August 29, 2006,
proposed rule requested comments on the information collection for
revised part 207. When the proposal is finalized, the information
collection for revised part 207 will replace the information
collection in this notice.
---------------------------------------------------------------------------
Under current Sec. Sec. 207.21 and 207.22, establishments, both
domestic and foreign, must register with FDA by submitting Form FDA-
2656 (Registration of Drug Establishment) within 5 days after beginning
the manufacture of drugs or biologicals, or within 5 days after the
submission of a drug application or biological license application. In
addition, establishments must register annually by returning, within 30
days of receipt from FDA, Form FDA-2656e (Annual Update of Drug
Establishment) (Note: This form is no longer mailed to registrants by
FDA; updating registration information is estimated in table 1 of this
document by the information submitted annually on Form FDA-2656).
Changes in individual ownership, corporate or partnership
[[Page 48657]]
structure, location, or drug-handling activity must be submitted as
amendments to registration under current Sec. 207.26 within 5 days of
such changes. Distributors that elect to submit drug listing
information must submit a Form FDA-2656 to FDA and a copy of the
completed form to the registered establishment that manufactured the
product to obtain a labeler code. Establishments must, within 5 days of
beginning the manufacture of drugs or biologicals, submit to FDA a
listing for every drug or biological product in commercial distribution
at that time by using Form FDA-2657 (Drug Product Listing). Private
label distributors may elect to submit to FDA a listing of every drug
product they place in commercial distribution. Registered
establishments must submit to FDA drug product listing for those
private label distributors who do not elect to submit listing
information by using Form FDA-2658 (Registered Establishments' Report
of Private Label Distributors).
Under current Sec. 207.25, product listing information submitted
to FDA by domestic and foreign manufacturers must, depending on the
type of product being listed, include any new drug application number
or biological establishment license number, copies of current labeling
and a sampling of advertisements, a quantitative listing of the active
ingredient for each drug or biological product not subject to an
approved application or license, the National Drug Code number, and any
drug imprinting information.
In addition to the product listing information required on Form
FDA-2657, FDA may also require, under current Sec. 207.31, a copy of
all advertisements and a quantitative listing of all ingredients for
each listed drug or biological product not subject to an approved
application or license; the basis for a determination, by the
establishment, that a listed drug or biological product is not subject
to marketing or licensing approval requirements; and a list of certain
drugs or biological products containing a particular ingredient. FDA
may also request, but not require, the submission of a qualitative
listing of the inactive ingredients for all listed drugs or biological
products, and a quantitative listing of the active ingredients for all
listed drugs or biological products subject to an approved application
or license.
Under current Sec. 207.30, establishments must update their
product listing information by using Form FDA-2657 and/or Form FDA-2658
every June and December or, at the discretion of the establishment,
when any change occurs. These updates must include the following
information: (1) A listing of all drug or biological products
introduced for commercial distribution that have not been included in
any previously submitted list; (2) all drug or biological products
formerly listed for which commercial distribution has been
discontinued; (3) all drug or biological products for which a notice of
discontinuance was submitted and for which commercial distribution has
been resumed; and (4) any material change in any information previously
submitted. No update is required if no changes have occurred since the
previously submitted list.
FDA estimates the annual information collection burden for current
part 207 as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of
Form No. of responses per Total annual Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
(1) Form FDA-2656 39 14.72 574 2.50 1,435
- Registration
of Drug
Establishment
(New
registrations,
including new
labeler codes
for private
label
distributors)
----------------------------------------------------------------------------------------------------------------
(2) Form FDA-2656 3,256 2.99 9,763 2.50 24,407.50
- Annual Update
of Drug
Establishment
(Update of
registration
information)
----------------------------------------------------------------------------------------------------------------
(3) Form FDA-2657 1,567 6.57 10,301 2.50 25,752.50
- Drug Product
Listing (New
drug listings)
----------------------------------------------------------------------------------------------------------------
(4) Form FDA-2658 146 10.06 1,469 2.50 3,672.50
- Registered
Establishments'
Report of
Private Label
Distributors
(New listings
for private
label
distributor
drugs)
----------------------------------------------------------------------------------------------------------------
(5) Form FDA-2657 1,677 11.21 18,797 2.50 46,992.50
and Form FDA-
2658 - (June and
December updates
of all listing
information)
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 102,260
----------------------------------------------------------------------------------------------------------------
[[Page 48658]]
Dated: August 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16795 Filed 8-23-07; 8:45 am]
BILLING CODE 4160-01-S
