Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Registration and Listing, 2413-2415 [05-676]
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2413
Federal Register / Vol. 70, No. 9 / Thursday, January 13, 2005 / Notices
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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.
State Petitions for Exemption From
Preemption—21 CFR 100.1(d) (OMB
Control Number 0910–0277)—Extension
Under section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 343–1(b)), States may petition
FDA for exemption from Federal
preemption of State food labeling and
standard of identity requirements.
Section 100.1(d) (21 CFR 100.1(d)) sets
forth the information a State is required
to submit in such a petition. The
information required under § 100.1(d)
enables FDA to determine whether the
State food labeling or standard of
identity requirement satisfies the
criteria of section 403A(b) of the act for
granting exemption from Federal
preemption.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR
Section
100.1(d)
1 There
Annual Frequency per
Response
Total Annual Responses
1
Number of Respondents
1
1
Hours per Response
40
Total Hours
40
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
insignificant because petitions for
exemption from preemption are seldom
submitted by States. In the last 3 years,
FDA has not received any new petitions;
therefore, the agency estimates that one
or fewer petitions will be submitted
annually. Because § 100.1(d)
implements a statutory information
collection requirement, only the
additional burden attributable to the
regulation has been included in the
estimate. Although FDA believes that
the burden will be insignificant, it
believes these information collection
provisions should be extended to
provide for the potential future need of
a State or local government to petition
for an exemption from preemption
under the provisions of section 403(A)
of the act.
Dated: January 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–674 Filed 1–12–05; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0436]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Registration and Listing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
14, 2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
PO 00000
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OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Device Registration and
Listing—21 CFR Parts 807.22, 807.31,
and 807.40 (OMB Control Number
0910–0387)—Extension
Section 510 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360) requires domestic establishments
engaged in the manufacture,
preparation, propagation, compounding,
assembly, or processing of medical
devices intended for human use and
commercial distribution register their
establishments and list the devices they
manufacture with FDA. This is
accomplished by completing FDA Form
2891 ‘‘Registration of Device
Establishment’’ and FDA Form 2892
‘‘Medical Device Listing.’’ The term
‘‘device’’ is defined in section 201(h) of
the act (21 U.S.C. 321) and includes all
in vitro diagnostic products and in vitro
diagnostic biological products not
subject to licensing under section 351 of
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Federal Register / Vol. 70, No. 9 / Thursday, January 13, 2005 / Notices
the Public Health Service Act (42 U.S.C.
262). The FDA Modernization Act of
1997 (FDAMA) added a requirement for
foreign establishments to appoint a U.S.
agent and submit the information to
FDA on Form 2891 as part of its initial
and updated registration information. In
addition, each year, active, registered
establishments must notify FDA of
changes to the current registration and
device listing for the establishment.
Annual changes to current registration
information are preprinted on FDA
Form 2891a and sent to registered
establishments. The form must be sent
back to FDA’s Center for Devices and
Radiological Health, even if no changes
have occurred. Changes to listing
information are submitted on Form
2892.
Under § 807.31 (21 CFR 807.31), each
owner or operator is required to
maintain an historical file containing
the labeling and advertisements in use
on the date of initial listing, and in use
after October 10, 1978, but before the
geographic distribution in order to
effectively allocate FDA’s field
resources for these inspections and to
identify the class of the device that
determines the inspection frequency.
When complications occur with a
particular device or component,
manufacturers of similar or related
devices can be easily identified.
The likely respondents to this
information collection will be domestic
and foreign device establishments and
U.S. agents who must register and
submit a device list to FDA (e.g.,
establishments engaged in the
manufacture, preparation, propagation,
compounding, assembly, or processing
of medical devices intended for human
use and commercial distribution).
In the Federal Register of October 29,
2004 (69 FR 63156), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
date of initial listing. The owner or
operator must maintain in the historical
file any labeling or advertisements in
which a material change has been made
anytime after initial listing, but may
discard labeling and advertisements
from the file 3 years after the date of the
last shipment of a discontinued device
by an owner or operator. Along with the
recordkeeping requirements previously
mentioned in this document, the owner
or operator must be prepared to submit
to FDA all labeling and advertising
(§ 807.31(e)).
Section 807.40 (21 CFR 807.40)
describes the role of the U.S. agent. The
U.S. agent must reside or have a
physical place of business in the United
States, and each foreign establishment
must submit U.S. agent information as
part of its initial and updated
registration process.
The information collected through
these provisions is used by FDA to
identify firms subject to FDA’s
regulations and is used to identify
ESTIMATED ANNUAL REPORTING BURDEN
TABLE 1A.—ESTIMATED YEAR 1 ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
FDA Form
807.22(a) and 807.40
Annual Frequency
of Response
Total Annual
Responses
Hours Per
Response
Form 2891 Initial and Updates
Establishment Registration
2,900
1
2,900
.25
725
Form 2892 Device Listing–
initial and updates
4,400
1
4,400
.50
2,200
Form 2891a–Registration
Update
25,100
1
25,100
.25
6,275
200
1
200
.50
100
807.22(b)
807.22(a) and 807.40
807.31(e)
Total Year 1 Burden Hours
1 There
Total
Hours
9,300
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 1B.—ESTIMATED SUBSEQUENT YEARS ANNUAL REPORTING BURDEN1
21 CFR Section
807.22(a) and 807.40
No. of
Respondents
FDA Form
Annual Frequency
of Response
Total Annual
Responses
3,100
1
3,100
.25
775
Form 2892 Device Listing–
initial and updates
4,600
1
4,600
.50
2,300
Form 2891a–Registration
Update
25,100
1
25,100
.25
6,275
200
1
200
.50
100
807.22(a) and 807.40
807.31(e)
Total Year 2 and 3 Burden Hours
9,450
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate jul<14>2003
Total
Hours
Form 2891 Initial and Updates
Establishment Registration
807.22(b)
1 There
Hours Per
Response
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Federal Register / Vol. 70, No. 9 / Thursday, January 13, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN
No. of
Recordkeepers
21 CFR Section
807.31
Annual Frequency
per Recordkeeper
16,200
4
Total Annual
Records
Hours Per
Recordkeeper
64,800
Total Hours
.50
Total Burden Hours
32,400
The burdens are explained as follows:
The annual reporting burden hours to
respondents for registering
establishments and listing devices is
estimated to be 9,450 hours, and
recordkeeping burden hours for
respondents is estimated to be 32,400
hours. The estimates cited in tables 1A,
1B, and 2 of this document are based
primarily upon the annual FDA
accomplishment report, which includes
actual FDA registration and listing
figures from fiscal year (FY) 2003. These
estimates are also based on FDA
estimates of FY 2003 data from current
systems, conversations with industry
and trade association representatives,
and from internal review of the
documents referred to in tables 1A, 1B,
and 2 of this document.
According to 21 CFR part 807, all
owners/operators are required to list,
and establishments and U.S. agents are
required to register. Each owner/
operator has an average of two
establishments, according to statistics
gathered from FDA’s registration and
listing database. The database has
25,100 active establishments listed in it.
Based on past experience, the agency
anticipated that approximately 7,300
registrations will be processed during
the first year, and 3,100 thereafter. FDA
anticipates reviewing 200 historical files
annually.
Dated: January 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–676 Filed 1–12–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004F–0546]
Alltech, Inc.; Filing of Food Additive
Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that Alltech, Inc., has filed a petition
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17:46 Jan 12, 2005
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Jkt 205001
proposing that the food additive
regulations be amended to provide for
the safe use of polyurethane polymer
coating in ruminant feed.
DATES: Submit written or electronic
comments by March 29, 2005.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Isabel Pocurull, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6853,
email: ipocurull@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 2253) has been filed by
Alltech, Inc., 3031 Catnip Hill Pike,
Nicholasville, KY 40356. The petition
proposes to amend the food additive
regulations in part 573 Food Additives
permitted in Feed and Drinking Water of
Animals (21 CFR part 573) to provide
for the safe use of polyurethane polymer
coating in ruminant feed.
The potential environmental impact
of this action is being reviewed. To
encourage public participation
consistent with regulations issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see ADDRESSES) for public review and
comment.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
PO 00000
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FDA will also place on public display
any amendments to, or comments on,
the petitioner’s environmental
assessment without further
announcement in the Federal Register.
If, based on its review, the agency finds
that an environmental impact statement
is not required and this petition results
in a regulation, the notice of availability
of the agency’s finding of no significant
impact and the evidence supporting that
finding will be published with the
regulation in the Federal Register in
accordance with 21 CFR 25.51(b).
Dated: January 3, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–673 Filed 1–12–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0549]
Draft Guidance for Industry on
Labeling Over-the-Counter Human
Drug Products; Questions and
Answers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Labeling OTC Human
Drug Products—Questions and
Answers.’’ This guidance is intended to
assist manufacturers, packers, and
distributors of over-the-counter (OTC)
drug products to implement the
agency’s regulation on standardized
content and format requirements for the
labeling of OTC drug products. This
draft guidance discusses labeling
questions that have been frequently
asked by manufacturers, packers, and
distributors in implementing the new
requirements. The labeling examples in
this draft guidance show various format
and content features and suggest how
OTC drug monograph labeling
information finalized before the new
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]]>Agencies
[Federal Register Volume 70, Number 9 (Thursday, January 13, 2005)]
[Notices]
[Pages 2413-2415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-676]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0436]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Registration and Listing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 14, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Registration and Listing--21 CFR Parts 807.22,
807.31, and 807.40 (OMB Control Number 0910-0387)--Extension
Section 510 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360) requires domestic establishments engaged in the
manufacture, preparation, propagation, compounding, assembly, or
processing of medical devices intended for human use and commercial
distribution register their establishments and list the devices they
manufacture with FDA. This is accomplished by completing FDA Form 2891
``Registration of Device Establishment'' and FDA Form 2892 ``Medical
Device Listing.'' The term ``device'' is defined in section 201(h) of
the act (21 U.S.C. 321) and includes all in vitro diagnostic products
and in vitro diagnostic biological products not subject to licensing
under section 351 of
[[Page 2414]]
the Public Health Service Act (42 U.S.C. 262). The FDA Modernization
Act of 1997 (FDAMA) added a requirement for foreign establishments to
appoint a U.S. agent and submit the information to FDA on Form 2891 as
part of its initial and updated registration information. In addition,
each year, active, registered establishments must notify FDA of changes
to the current registration and device listing for the establishment.
Annual changes to current registration information are preprinted on
FDA Form 2891a and sent to registered establishments. The form must be
sent back to FDA's Center for Devices and Radiological Health, even if
no changes have occurred. Changes to listing information are submitted
on Form 2892.
Under Sec. 807.31 (21 CFR 807.31), each owner or operator is
required to maintain an historical file containing the labeling and
advertisements in use on the date of initial listing, and in use after
October 10, 1978, but before the date of initial listing. The owner or
operator must maintain in the historical file any labeling or
advertisements in which a material change has been made anytime after
initial listing, but may discard labeling and advertisements from the
file 3 years after the date of the last shipment of a discontinued
device by an owner or operator. Along with the recordkeeping
requirements previously mentioned in this document, the owner or
operator must be prepared to submit to FDA all labeling and advertising
(Sec. 807.31(e)).
Section 807.40 (21 CFR 807.40) describes the role of the U.S.
agent. The U.S. agent must reside or have a physical place of business
in the United States, and each foreign establishment must submit U.S.
agent information as part of its initial and updated registration
process.
The information collected through these provisions is used by FDA
to identify firms subject to FDA's regulations and is used to identify
geographic distribution in order to effectively allocate FDA's field
resources for these inspections and to identify the class of the device
that determines the inspection frequency. When complications occur with
a particular device or component, manufacturers of similar or related
devices can be easily identified.
The likely respondents to this information collection will be
domestic and foreign device establishments and U.S. agents who must
register and submit a device list to FDA (e.g., establishments engaged
in the manufacture, preparation, propagation, compounding, assembly, or
processing of medical devices intended for human use and commercial
distribution).
In the Federal Register of October 29, 2004 (69 FR 63156), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden
Table 1A.--Estimated Year 1 Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours Per Total
21 CFR Section FDA Form Respondents of Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(a) and 807.40 Form 2891 Initial and 2,900 1 2,900 .25 725
Updates Establishment
Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b) Form 2892 Device Listing- 4,400 1 4,400 .50 2,200
initial and updates
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(a) and 807.40 Form 2891a-Registration 25,100 1 25,100 .25 6,275
Update
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.31(e) ............................ 200 1 200 .50 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Year 1 Burden Hours 9,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1B.--Estimated Subsequent Years Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours Per Total
21 CFR Section FDA Form Respondents of Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(a) and 807.40 Form 2891 Initial and 3,100 1 3,100 .25 775
Updates Establishment
Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b) Form 2892 Device Listing- 4,600 1 4,600 .50 2,300
initial and updates
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(a) and 807.40 Form 2891a-Registration 25,100 1 25,100 .25 6,275
Update
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.31(e) ............................ 200 1 200 .50 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Year 2 and 3 Burden Hours 9,450
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 2415]]
Table 2.--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours Per
21 CFR Section No. of Recordkeepers per Recordkeeper Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.31 16,200 4 64,800 .50 32,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Burden Hours 32,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
The burdens are explained as follows:
The annual reporting burden hours to respondents for registering
establishments and listing devices is estimated to be 9,450 hours, and
recordkeeping burden hours for respondents is estimated to be 32,400
hours. The estimates cited in tables 1A, 1B, and 2 of this document are
based primarily upon the annual FDA accomplishment report, which
includes actual FDA registration and listing figures from fiscal year
(FY) 2003. These estimates are also based on FDA estimates of FY 2003
data from current systems, conversations with industry and trade
association representatives, and from internal review of the documents
referred to in tables 1A, 1B, and 2 of this document.
According to 21 CFR part 807, all owners/operators are required to
list, and establishments and U.S. agents are required to register. Each
owner/operator has an average of two establishments, according to
statistics gathered from FDA's registration and listing database. The
database has 25,100 active establishments listed in it. Based on past
experience, the agency anticipated that approximately 7,300
registrations will be processed during the first year, and 3,100
thereafter. FDA anticipates reviewing 200 historical files annually.
Dated: January 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-676 Filed 1-12-05; 8:45 am]
BILLING CODE 4160-01-S
