Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products, 64714-64718 [E6-18559]
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Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices
annual responses in FY 2005 included
the cover sheets for applications that
were qualified for small businesses and
fee waivers or reductions. The estimated
hours per response are based on past
FDA experience with the various cover
sheet submissions, and range from 5 to
30 minutes. The hours per response are
based on the average of these estimates.
In the Federal Register of June 29,
2006 (71 FR 37082), FDA published a
60-day notice soliciting comments on
the proposed collection of information.
In response to that notice, one comment
was received regarding the MDUFMA
cover sheet. FDA responded as follows
‘‘The current layout of the online form
is to ensure information and questions
presented on the Web site are easy to
read for all users. When this system was
constructed, the Food and Drug
Administration was limited to the
format and the layout of questions and
answers. FDA took an already approved
form and created an interactive system
that determines the payments of
requested applications based on the
answers to the questions. The questions
are sequential. After completing the first
question, the system decides and
chooses the next question for the
customers. This Federal Register notice
renews the current construction. Careful
consideration during the next review
will be given and FDA will certainly
consider the commenter’s suggestion of
saving screen refresh time.’’
As noted previously, FDA will be glad
to take under consideration the
commenter’s template and the ability to
download the form, when the next
update or review is initiated. You can,
however, retrieve an existing cover
sheet by logging into the system, and
clicking on the name of the cover sheet.
The retrieved form is a photo shot html
format. Thus, no changes can be made
directly onto the form. To print the
cover sheet, please select ‘‘Print Cover
Sheet’’ on the bottom of the form.
Currently, the printed cover sheet
contains all information on one page.
Again, FDA will be glad to consider this
request during the next review. The
current cover sheet is designed to
contain all information on one page. By
creating more room on the left margin,
the form may extend to two pages.
Having instructions 1 through 6 on
the cover sheet seems redundant.
However, at the time, when creating the
interactive system, FDA took into
consideration that once a cover sheet is
completed and ready to mail, all
information would be displayed on the
same page. Instructions 1 through 6 are
very important information for all
customers to follow in order to expedite
the application review process. The
instructions printed on the cover sheet
provide easy access for all customers to
learn about them, especially for new
users. FDA will continue to use the
current form. For other questions
regarding submitted cover sheets, please
contact the User Fee Hotline at 301–
827–9539, or e-mail the User Fee
Financial Support Team at
userfees@fda.gov.
The most likely respondents would be
medical device manufacturers.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Form FDA No.
3601
Annual Frequency
per Response
4,600
Total Annual
Responses
1
Hours per
Response
4,600
0.30
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18557 Filed 11–2–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0427]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reporting and
Recordkeeping Requirements and
Availability of Sample Electronic
Products for Manufacturers and
Distributors of Electronic Products
AGENCY:
Submit written or electronic
comments on the collection of
information by January 2, 2007.
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
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Jkt 211001
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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
ADDRESSES:
Food and Drug Administration,
VerDate Aug<31>2005
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 information
collection, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection requirements for
reporting and recordkeeping, general
and specific requirements, and the
availability of sample electronic
products for manufacturers and
distributors of electronic products.
DATES:
HHS.
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1,380
1,380
1There
ACTION:
Total Hours
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docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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
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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.
Reporting and Recordkeeping
Requirements and Availability of
Sample Electronic Products for
Manufacturers and Distributors of
Electronic Products (OMB Control
Number 0910–0025)—Extension
Under sections 532 through 542 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360ii through 360ss),
FDA has the responsibility to protect the
public from unnecessary exposure of
radiation from electronic products. The
regulations issued under these
authorities are listed in the Code of
Federal Regulations, title 21, chapter I,
subpart J. Specifically, subpart A
regulations, 21 CFR 5.10(a)(3), 5.25(b),
5.35(a)(4), and 5.600 through 5.606,
delegate administrative authorities to
FDA.
Section 532 of the act directs the
Secretary of the Department of Health
and Human Services (the Secretary), to
establish and carry out an electronic
product radiation control program,
including the development, issuance,
and administration of performance
standards to control the emission of
electronic product radiation from
electronic products. The program is
designed to protect the public health
and safety from electronic radiation, and
the act authorizes the Secretary to
procure (by negotiation or otherwise)
electronic products for research and
testing purposes and to sell or otherwise
dispose of such products.
Section 534(g) of the act directs the
Secretary to review and evaluate
industry testing programs on a
continuing basis; and section 535(e) and
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(f) of the act directs the Secretary to
immediately notify manufacturers of,
and ensure correction of, radiation
defects or noncompliances with
performance standards.
Section 537(b) of the act contains the
authority to require manufacturers of
electronic products to establish and
maintain records (including testing
records), make reports, and provide
information to determine whether the
manufacturer has acted in compliance.
Parts 1002 through 1010 (21 CFR parts
1002 through 1010) specify reports to be
provided by manufacturers and
distributors to FDA and records to be
maintained in the event of an
investigation of a safety concern or a
product recall.
FDA conducts laboratory compliance
testing of products covered by
regulations for product standards in
parts 1020, 1030, 1040, and 1050 (21
CFR parts 1020, 1030, 1040, and 1050).
FDA details product-specific
performance standards that specify
information to be supplied with the
product or require specific reports. The
information collections are either
specifically called for in the act or were
developed to aid the agency in
performing its obligations under the act.
The data reported to FDA and the
records maintained are used by FDA
and the industry to make decisions and
take actions that protect the public from
radiation hazards presented by
electronic products. This information
refers to the identification of, location
of, operational characteristics of, quality
assurance programs for, and problem
identification and correction of
electronic products. The data provided
to users and others are intended to
encourage actions to reduce or eliminate
radiation exposures.
FDA uses the following forms to aid
respondents in the submission of
information for this information
collection:
FDA Form 2579 ‘‘Report of Assembly
of a Diagnostic X-ray System’’
FDA Form 2767 ‘‘Notice of
Availability of Sample Electronic
Product’’
FDA Form 2877 ‘‘Declaration for
Imported Electronic Products Subject To
Radiation Control Standards’’
FDA Form 3649 ‘‘Accidental
Radiation Occurrence’’
FDA Form 3626 ‘‘A Guide for the
Submission of Initial Reports on
Diagnostic X-ray Systems and Their
Major Components’’
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FDA Form 3627 ‘‘Diagnostic X-ray CT
Products Radiation Safety Report’’
FDA Form 3628 ‘‘General Annual
Report (Includes Medical, Analytical,
and Industrial X-ray Products Annual
Report)’’
FDA Form 3629 ‘‘Abbreviated Report’’
FDA Form 3630 ‘‘Guide for Preparing
Product Reports on Sunlamps and
Sunlamp Products’’
FDA Form 3631 ‘‘Guide for Preparing
Annual Reports on Radiation Safety
Testing of Sunlamps and Sunlamp
Products’’
FDA Form 3632 ‘‘Guide for Preparing
Product Reports on Lasers and Products
Containing Lasers’’
FDA Form 3633 ‘‘General Variance
Request’’
FDA Form 3634 ‘‘Television Products
Annual Report’’
FDA Form 3635 ‘‘Laser Light Show
Notification’’
FDA Form 3636 ‘‘Guide for Preparing
Annual Reports on Radiation Safety
Testing of Laser and Laser Light Show
Products’’
FDA Form 3637 ‘‘Laser Original
Equipment Manufacturer (OEM)
Report’’
FDA Form 3638 ‘‘Guide for Filing
Annual Reports for X-ray Components
and Systems’’
FDA Form 3639 ‘‘Guidance for the
Submission of Cabinet X-ray System
Reports Pursuant to 21 CFR 1020.40’’
FDA Form 3640 ‘‘Reporting Guide for
Laser Light Shows and Displays’’
FDA Form 3147 ‘‘Application for a
Variance From 21 CFR 1040.11(c) for a
Laser Light Show, Display, or Device’’
FDA Form 3641 ‘‘Cabinet X-ray
Annual Report’’
FDA Form 3642 ‘‘General
Correspondence’’
FDA Form 3643 ‘‘Microwave Oven
Products Annual Report’’
FDA Form 3644 ‘‘Guide for Preparing
Product Reports for Ultrasonic Therapy
Products’’
FDA Form 3645 ‘‘Guide for Preparing
Annual Reports for Ultrasonic Therapy
Products’’
FDA Form 3646 ‘‘Mercury Vapor
Lamp Products Radiation Safety Report’’
FDA Form 3647 ‘‘Guide for Preparing
Annual Reports on Radiation Safety
Testing of Mercury Vapor Lamps’’
The most likely respondents to this
information collection will be electronic
product and x-ray manufacturers,
importers, and assemblers.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FDA Form
Number
21 CFR Section
No. of
Respondents
1002.3
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
10
1
10
12
120
540
1.6
850
24
20,400
1,000
1.5
1,500
0.5
750
150
1
150
5
750
900
1
900
26
23,400
250
2.4
600
0.5
300
40
1
40
2
80
1
1
1
1
1
10
1.5
15
1
15
145
11.03
1,600
0.09
144
1
1
1
1
1
600
32
19,200
0.2
3,840
1
1
1
5
5
1
1
1
120
120
1010.5(c) and (d)
2
1
2
22
44
1010.13
1
1
1
10
10
1020.20(c)(4)
1
1
1
1
1
2,345
8.96
21,000
0.30
6,300
1020.30(g)
200
1.33
265
35
9,275
1020.30(h)(1) through
(h)(4), 1020.32(a)(1)
and (g)
200
1.33
265
35
9,275
20
5
100
180
18,000
1002.10
3626—Diagnostic X-Ray
3627—CT X-Ray
3639—Cabinet X-Ray
3632—Laser
3640—Laser Light Show
3630—Sunlamp
3646—Mercury Vapor Lamp
3644—Ultrasonic Therapy
1002.11
1002.12
3629—Abbreviated Report
1002.13
3628—General
3634—TV
3638—Diagnostic X-Ray
3641—Cabinet X-Ray
3643—Microwave Oven
3636—Laser
3631—Sunlamp
3647—Mercury Vapor Lamp
3645—Ultrasonic Therapy
1002.13
1002.20
3649—ARO
1002.41(a)
1002.50(a) and
1002.51
3642—General Correspondence
1005.10
2767—Sample Product
1005.25(b)
2877—Imports Declaration
1010.2 and 1010.3
1010.4(b)
3633—General Variance Request
3147—Laser Show Variance
Request
3635—Laser Show Notification
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1020.30(d), (d)(1), and
(d)(2)
2579—Assembler Report
1020.30(h)(5) and
(h)(6) and
1020.32(j)(4)
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Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
FDA Form
Number
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
1020.32(g) and
1020.33(c), (d),
(g)(4), (j)(3), and
(j)(4)
9
1.00
9
40
360
1020.40(c)(9)(i) and
(c)(9)(ii)
8
1.00
8
40
320
1030.10(c)(4)
41
1.61
66
20
1,320
1030.10(c)(5)(i)
through (c)(5)(iv)
41
1.61
66
20
1,320
1
1
1
1
1
83
1
83
3
249
1040.10(h)(1)(i)
through (h)(1)(vi)
805
1.00
805
8
6,440
1040.10(h)(2)(i) and
(h)(2)(ii)
100
1.00
100
8
800
1040.11(a)(2)
190
1.00
190
10
1,900
1040.20 (d)(1)(ii)-(vi),
(e)(1), and (e)(2)
110
1.00
110
10
1,100
1040.30(c)(1)(ii)
1
1.00
1
1
1
1040.30(c)(2)
7
1.00
7
1
7
10
1.00
10
56
560
1030.10(c)(6)(iii) and
(c)(6)(iv)
1040.10(a)(3)(i)
3637—OEM Report
1050.10(d)(1)-(d)(4)
and (f)(1)-(f)(2)(iii)
Total
1 There
107,209
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
1002.30 and 1002.31(a)
1,150
1,655.5
1,903,825
198.7
228,505
1002.40 and 1002.41
2,950
49.2
145,140
2.4
7,080
1020.30(g)
22
1
22
0.5
11
1040.10(a)(3)(ii)
83
1
83
1.0
83
Totals
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1 There
235,679
are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection, OMB
control number 0910–0564 (i.e. FDA
Form 3626) has been consolidated
under this information collection thus,
requiring an adjustment of the burden
estimate.
The burden estimates were derived by
consultation with FDA and industry
personnel and actual data collected
from industry. An evaluation of the type
and scope of information requested was
also used to derive some time estimates.
For example, disclosure information
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15:24 Nov 02, 2006
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primarily requires time only to update
and maintain existing manuals. Initial
development of manuals has been
performed except for new firms entering
the industry. When information is
generally provided to users, assemblers,
or dealers in the same manual, they
have been grouped together in the
‘‘Estimated Annual Reporting Burden’’
table.
The following information collection
requirements are not subject to review
by OMB because they do not constitute
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a ‘‘collection of information’’ under the
PRA: Sections 1002.31(c); 1003.10(a),
(b), and (c); 1003.11(a)(3) and (b);
1003.20(a) through (h); 1003.21(a)
through (d); 1003.22(a) and (b);
1003.30(a) and (b); 1003.31(a) and (b);
1004.2(a) through (i); 1004.3(a) through
(i); 1004.4(a) through (h); 1005.21(a)
through (c); and 1005.22(b). These
requirements ‘‘apply to the collection of
information during the conduct of
general investigations or audits’’ (5 CFR
1320.4(b)). The following labeling
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Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices
requirements are also not subject to
review under the PRA because they are
a public disclosure of information
originally supplied by the Federal
Government to the recipient for the
purpose of disclosure to the public (5
CFR 1320.3(c)(2)): Sections 21 CFR
1020.10(c)(4), 1030.10(c)(6), 1040.10(g),
1040.30(c)(1), and 1050.10(d)(1).
Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18559 Filed 11–2–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0326]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Inspection by
Accredited Persons Program Under
the Medical Device User Fee and
Modernization Act of 2002
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 December
4, 2006.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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 Devices: Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002 (OMB
Control Number 0910–0510)—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) was signed into
law on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph ‘‘g’’ to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
374), directing FDA to accredit third
parties (accredited persons or APs) to
conduct inspections of eligible
manufacturers of class II or class III
devices. This is a voluntary program.
FDA has a guidance document that
provides information for those
interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
In the Federal Register of August 24,
2006 (71 FR 50067), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
Respondents are expected to be
businesses or other for profit
organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Information Collection
No. of
Respondents
Request for Accreditation
Annual Frequency
per Response
3
Total Annual
Responses
1
Hours per
Response
3
80
Total Hours
1There
240
240
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on
conversations with industry, trade
association representatives, and internal
FDA estimates. Once an organization is
accredited, it will not be required to
reapply.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18603 Filed 11–2–06; 8:45 am]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
016
BILLING CODE 4160–01–S
AGENCY:
Food and Drug Administration
[Docket No. 2004N–0226]
Food and Drug Administration,
HHS.
ACTION:
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Total Hours
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA recognized
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consensus standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 016’’ (Recognition List
Number: 016), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit written or electronic
comments concerning this document at
any time. See section VII of this
document for the effective date of the
recognition of standards announced in
this document.
ADDRESSES: Submit written requests for
single copies of ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 016’’ to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
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]]>Agencies
[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64714-64718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18559]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0427]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting and Recordkeeping Requirements and
Availability of Sample Electronic Products for Manufacturers and
Distributors of Electronic Products
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 information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for reporting and recordkeeping, general and specific
requirements, and the availability of sample electronic products for
manufacturers and distributors of electronic products.
DATES: Submit written or electronic comments on the collection of
information by January 2, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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
[[Page 64715]]
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.
Reporting and Recordkeeping Requirements and Availability of Sample
Electronic Products for Manufacturers and Distributors of Electronic
Products (OMB Control Number 0910-0025)--Extension
Under sections 532 through 542 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360ii through 360ss), FDA has the
responsibility to protect the public from unnecessary exposure of
radiation from electronic products. The regulations issued under these
authorities are listed in the Code of Federal Regulations, title 21,
chapter I, subpart J. Specifically, subpart A regulations, 21 CFR
5.10(a)(3), 5.25(b), 5.35(a)(4), and 5.600 through 5.606, delegate
administrative authorities to FDA.
Section 532 of the act directs the Secretary of the Department of
Health and Human Services (the Secretary), to establish and carry out
an electronic product radiation control program, including the
development, issuance, and administration of performance standards to
control the emission of electronic product radiation from electronic
products. The program is designed to protect the public health and
safety from electronic radiation, and the act authorizes the Secretary
to procure (by negotiation or otherwise) electronic products for
research and testing purposes and to sell or otherwise dispose of such
products.
Section 534(g) of the act directs the Secretary to review and
evaluate industry testing programs on a continuing basis; and section
535(e) and (f) of the act directs the Secretary to immediately notify
manufacturers of, and ensure correction of, radiation defects or
noncompliances with performance standards.
Section 537(b) of the act contains the authority to require
manufacturers of electronic products to establish and maintain records
(including testing records), make reports, and provide information to
determine whether the manufacturer has acted in compliance.
Parts 1002 through 1010 (21 CFR parts 1002 through 1010) specify
reports to be provided by manufacturers and distributors to FDA and
records to be maintained in the event of an investigation of a safety
concern or a product recall.
FDA conducts laboratory compliance testing of products covered by
regulations for product standards in parts 1020, 1030, 1040, and 1050
(21 CFR parts 1020, 1030, 1040, and 1050).
FDA details product-specific performance standards that specify
information to be supplied with the product or require specific
reports. The information collections are either specifically called for
in the act or were developed to aid the agency in performing its
obligations under the act. The data reported to FDA and the records
maintained are used by FDA and the industry to make decisions and take
actions that protect the public from radiation hazards presented by
electronic products. This information refers to the identification of,
location of, operational characteristics of, quality assurance programs
for, and problem identification and correction of electronic products.
The data provided to users and others are intended to encourage actions
to reduce or eliminate radiation exposures.
FDA uses the following forms to aid respondents in the submission
of information for this information collection:
FDA Form 2579 ``Report of Assembly of a Diagnostic X-ray System''
FDA Form 2767 ``Notice of Availability of Sample Electronic
Product''
FDA Form 2877 ``Declaration for Imported Electronic Products
Subject To Radiation Control Standards''
FDA Form 3649 ``Accidental Radiation Occurrence''
FDA Form 3626 ``A Guide for the Submission of Initial Reports on
Diagnostic X-ray Systems and Their Major Components''
FDA Form 3627 ``Diagnostic X-ray CT Products Radiation Safety
Report''
FDA Form 3628 ``General Annual Report (Includes Medical,
Analytical, and Industrial X-ray Products Annual Report)''
FDA Form 3629 ``Abbreviated Report''
FDA Form 3630 ``Guide for Preparing Product Reports on Sunlamps and
Sunlamp Products''
FDA Form 3631 ``Guide for Preparing Annual Reports on Radiation
Safety Testing of Sunlamps and Sunlamp Products''
FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and
Products Containing Lasers''
FDA Form 3633 ``General Variance Request''
FDA Form 3634 ``Television Products Annual Report''
FDA Form 3635 ``Laser Light Show Notification''
FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation
Safety Testing of Laser and Laser Light Show Products''
FDA Form 3637 ``Laser Original Equipment Manufacturer (OEM)
Report''
FDA Form 3638 ``Guide for Filing Annual Reports for X-ray
Components and Systems''
FDA Form 3639 ``Guidance for the Submission of Cabinet X-ray System
Reports Pursuant to 21 CFR 1020.40''
FDA Form 3640 ``Reporting Guide for Laser Light Shows and
Displays''
FDA Form 3147 ``Application for a Variance From 21 CFR 1040.11(c)
for a Laser Light Show, Display, or Device''
FDA Form 3641 ``Cabinet X-ray Annual Report''
FDA Form 3642 ``General Correspondence''
FDA Form 3643 ``Microwave Oven Products Annual Report''
FDA Form 3644 ``Guide for Preparing Product Reports for Ultrasonic
Therapy Products''
FDA Form 3645 ``Guide for Preparing Annual Reports for Ultrasonic
Therapy Products''
FDA Form 3646 ``Mercury Vapor Lamp Products Radiation Safety
Report''
FDA Form 3647 ``Guide for Preparing Annual Reports on Radiation
Safety Testing of Mercury Vapor Lamps''
The most likely respondents to this information collection will be
electronic product and x-ray manufacturers, importers, and assemblers.
FDA estimates the burden of this collection of information as
follows:
[[Page 64716]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section FDA Form Number Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
1002.3 ................... 10 1 10 12 120
----------------------------------------------------------------------------------------------------------------
1002.10 ................... 540 1.6 850 24 20,400
3626--Diagnostic X-
Ray
3627--CT X-Ray
3639--Cabinet X-Ray
3632--Laser
3640--Laser Light
Show
3630--Sunlamp
3646--Mercury Vapor
Lamp
3644--Ultrasonic
Therapy
----------------------------------------------------------------------------------------------------------------
1002.11 ................... 1,000 1.5 1,500 0.5 750
----------------------------------------------------------------------------------------------------------------
1002.12 3629--Abbreviated 150 1 150 5 750
Report
----------------------------------------------------------------------------------------------------------------
1002.13 ................... 900 1 900 26 23,400
3628--General
3634--TV
3638--Diagnostic X-
Ray
3641--Cabinet X-Ray
3643--Microwave
Oven
3636--Laser
3631--Sunlamp
3647--Mercury Vapor
Lamp
3645--Ultrasonic
Therapy
----------------------------------------------------------------------------------------------------------------
1002.13 ................... 250 2.4 600 0.5 300
----------------------------------------------------------------------------------------------------------------
1002.20 3649--ARO 40 1 40 2 80
----------------------------------------------------------------------------------------------------------------
1002.41(a) ................... 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
1002.50(a) and 3642--General 10 1.5 15 1 15
1002.51 Correspondence
----------------------------------------------------------------------------------------------------------------
1005.10 2767--Sample 145 11.03 1,600 0.09 144
Product
----------------------------------------------------------------------------------------------------------------
1005.25(b) ................... 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
2877--Imports 600 32 19,200 0.2 3,840
Declaration
----------------------------------------------------------------------------------------------------------------
1010.2 and ................... 1 1 1 5 5
1010.3
----------------------------------------------------------------------------------------------------------------
1010.4(b) ................... 1 1 1 120 120
3633--General
Variance Request
3147--Laser Show
Variance Request
3635--Laser Show
Notification
----------------------------------------------------------------------------------------------------------------
1010.5(c) and ................... 2 1 2 22 44
(d)
----------------------------------------------------------------------------------------------------------------
1010.13 ................... 1 1 1 10 10
----------------------------------------------------------------------------------------------------------------
1020.20(c)(4) ................... 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
1020.30(d), 2579--Assembler 2,345 8.96 21,000 0.30 6,300
(d)(1), and Report
(d)(2)
----------------------------------------------------------------------------------------------------------------
1020.30(g) ................... 200 1.33 265 35 9,275
----------------------------------------------------------------------------------------------------------------
1020.30(h)(1) ................... 200 1.33 265 35 9,275
through
(h)(4),
1020.32(a)(1)
and (g)
----------------------------------------------------------------------------------------------------------------
1020.30(h)(5) ................... 20 5 100 180 18,000
and (h)(6)
and
1020.32(j)(4)
----------------------------------------------------------------------------------------------------------------
[[Page 64717]]
1020.32(g) and ................... 9 1.00 9 40 360
1020.33(c),
(d), (g)(4),
(j)(3), and
(j)(4)
----------------------------------------------------------------------------------------------------------------
1020.40(c)(9)( ................... 8 1.00 8 40 320
i) and
(c)(9)(ii)
----------------------------------------------------------------------------------------------------------------
1030.10(c)(4) ................... 41 1.61 66 20 1,320
----------------------------------------------------------------------------------------------------------------
1030.10(c)(5)( ................... 41 1.61 66 20 1,320
i) through
(c)(5)(iv)
----------------------------------------------------------------------------------------------------------------
1030.10(c)(6)( ................... 1 1 1 1 1
iii) and
(c)(6)(iv)
----------------------------------------------------------------------------------------------------------------
1040.10(a)(3)( 3637--OEM Report 83 1 83 3 249
i)
----------------------------------------------------------------------------------------------------------------
1040.10(h)(1)( ................... 805 1.00 805 8 6,440
i) through
(h)(1)(vi)
----------------------------------------------------------------------------------------------------------------
1040.10(h)(2)( ................... 100 1.00 100 8 800
i) and
(h)(2)(ii)
----------------------------------------------------------------------------------------------------------------
1040.11(a)(2) ................... 190 1.00 190 10 1,900
----------------------------------------------------------------------------------------------------------------
1040.20 ................... 110 1.00 110 10 1,100
(d)(1)(ii)-
(vi), (e)(1),
and (e)(2)
----------------------------------------------------------------------------------------------------------------
1040.30(c)(1)( ................... 1 1.00 1 1 1
ii)
----------------------------------------------------------------------------------------------------------------
1040.30(c)(2) ................... 7 1.00 7 1 7
----------------------------------------------------------------------------------------------------------------
1050.10(d)(1)- ................... 10 1.00 10 56 560
(d)(4) and
(f)(1)-
(f)(2)(iii)
----------------------------------------------------------------------------------------------------------------
Total 107,209
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
1002.30 and 1,150 1,655.5 1,903,825 198.7 228,505
1002.31(a)
----------------------------------------------------------------------------------------------------------------
1002.40 and 2,950 49.2 145,140 2.4 7,080
1002.41
----------------------------------------------------------------------------------------------------------------
1020.30(g) 22 1 22 0.5 11
----------------------------------------------------------------------------------------------------------------
1040.10(a)(3)(ii) 83 1 83 1.0 83
----------------------------------------------------------------------------------------------------------------
Totals 235,679
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The information collection, OMB control number 0910-0564 (i.e. FDA
Form 3626) has been consolidated under this information collection
thus, requiring an adjustment of the burden estimate.
The burden estimates were derived by consultation with FDA and
industry personnel and actual data collected from industry. An
evaluation of the type and scope of information requested was also used
to derive some time estimates. For example, disclosure information
primarily requires time only to update and maintain existing manuals.
Initial development of manuals has been performed except for new firms
entering the industry. When information is generally provided to users,
assemblers, or dealers in the same manual, they have been grouped
together in the ``Estimated Annual Reporting Burden'' table.
The following information collection requirements are not subject
to review by OMB because they do not constitute a ``collection of
information'' under the PRA: Sections 1002.31(c); 1003.10(a), (b), and
(c); 1003.11(a)(3) and (b); 1003.20(a) through (h); 1003.21(a) through
(d); 1003.22(a) and (b); 1003.30(a) and (b); 1003.31(a) and (b);
1004.2(a) through (i); 1004.3(a) through (i); 1004.4(a) through (h);
1005.21(a) through (c); and 1005.22(b). These requirements ``apply to
the collection of information during the conduct of general
investigations or audits'' (5 CFR 1320.4(b)). The following labeling
[[Page 64718]]
requirements are also not subject to review under the PRA because they
are a public disclosure of information originally supplied by the
Federal Government to the recipient for the purpose of disclosure to
the public (5 CFR 1320.3(c)(2)): Sections 21 CFR 1020.10(c)(4),
1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 1050.10(d)(1).
Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18559 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S
