[Federal Register: October 7, 2003 (Volume 68, Number 194)]
[Notices]
[Page 57909-57911]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc03-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0213]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by
November 6, 2003.
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.
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 from
radiation from electronic products. The regulations issued under these
authorities are listed in 21 CFR chapter I, subchapter J. Specifically,
subchapter 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 sections
535(e) and (f) of the act direct 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 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
[[Page 57910]]
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: (1) Form FDA 2767,
``Notice of Availability of Sample Electronic Product;'' (2) Form FDA
2877, ``Declaration for Imported Electronic Products Subject to
Radiation Control Standards,'' and (3) Form FDA 3147, ``Application for
a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or
Device.''
The most likely respondents to this information collection will be
electronic product and x ray manufacturers, importers, and assemblers.
In the Federal Register of June 12, 2003 (68 FR 35231), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received two comments on the FDA radiation
program paperwork burden (under OMB control number 0910-0025). One
comment pertained to the information collection. It stated that the
Occupational Safety and Health Administration and the Department of
Health and Human Services (DHHS) already have radiation standards and
that government paperwork on radiation emissions is of dubious value
until more research is conducted, particularly on nonthermal effects of
microwave/radiofrequency radiation. FDA is the agency of DHHS that is
responsible for radiation safety standards for electronic products.
Industry paperwork on radiation safety provides the agency with
critical information on radiation controls, such as safety interlocks,
timers, warning labels, etc., and on radiation emissions that are
compared to known bioeffects hazards, whether specified in mandatory
FDA standards or more recent consensus standards. Specifically,
information provided to FDA on microwave radiation is compared to
levels known to cause thermal injuries.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
21 CFR Section Form No. No. of Respondents per Response Responses Response Total Hours
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1002.3 .......... 10 1 10 12 120
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1002.10 and 1010.3 .......... 540 1.6 850 24 20,400
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1002.11 .......... 1,000 1.5 1,500 0.5 750
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1002.12 .......... 150 1 150 5 750
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1002.13 annual .......... 900 1 900 26 23,400
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1002.13 quarterly .......... 250 2.4 600 0.5 300
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1002.20 .......... 40 1 40 2 80
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1002.50(a) and .......... 10 1.5 15 1 15
1002.51
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FDA 2877 600 32 19,200 0.2 3,840
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1010.2 .......... 1 1 1 5 5
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1010.4(b) .......... 1 1 1 120 120
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1010.5 and 1010.13 .......... 3 1 3 22 66
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FDA 2767 145 11.03 1,600 0.09 144
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1020.20(c)(4) .......... 1 1 1 1 1
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1020.30(d), FDA 2579 2,345 8.96 21,000 0.30 6,300
(d)(1), and
(d)(2)
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1020.30(g) .......... 200 1.33 265 35 9,275
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1020.30(h)(1) .......... 200 1.33 265 35 9,275
through
(h)(4),1020.32(a)
(1) and (g)
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1020.32(g) and .......... 9 1 9 40 360
1020.33(c), (d),
(g)(4), (j)(1),
and (j)(2)
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1020.40(c)(9)(i) .......... 8 1 8 40 320
and (c)(9)(ii)
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1030.10(c)(4) .......... 41 1.61 66 20 1,320
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1030.10(c)(5)(i) .......... 41 1.61 66 20 1,320
through
(c)(5)(iv)
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1030.10(c)(6)(iii) .......... 1 1 1 1 1
and (c)(6)(iv)
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1040.10(a)(3)(i) .......... 83 1 83 3 249
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1040.10(h)(1)(i) .......... 805 1 805 8 6,440
through
(h)(1)(vi)
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1040.10(h)(2)(i) .......... 100 1 100 8 800
and (h)(2)(ii)
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1040.11(a)(2) .......... 190 1 190 10 1,900
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1040.11(c) FDA 3147 53 2.2 115 0.5 58
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1040.20 (d), .......... 110 1 110 10 1,100
(e)(1), and
(e)(2)
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1040.30(c)(1) .......... 1 1 1 1 1
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1040.30(c)(2) .......... 7 1 7 1 7
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1050.10(f)(1) .......... 10 1 10 56 560
through
(f)(2)(iii)
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Total Annual Reporting Burden 89,278
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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21 CFR Annual Frequency Total Annual
Section No. of Recordkeepers of Recordkeeping Records Hours per Recordkeeper Total Hours
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1002.30 and 1,150 1,655.5 1,903,825 198.7 228,505
1002.31(a)
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1002.40 and 2,950 49.2 145,140 2.4 7,080
1002.41
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1020.30(g)(2) 22 1 22 0.5 11
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1040.10(a)(3) 83 1 83 1.0 83
(ii)
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Totals 235,679
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates were derived by consultation with FDA and
industry personnel and actual data collected from industry over the
past 3 years. 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 table 1 of this document.
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);
and 1005.21(a) through (c). These requirements ``apply to the
collection of information during the conduct of general investigations
or audits'' (5 CFR 1320.4(b)). According to 5 CFR 1320.3(c)(2), the
following labeling 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: Sections 1020.10(c)(4), 1030.10(c)(6),
1040.10(g), 1040.30(c)(1), and 1050.10(d)(1).
Dated: September 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25304 Filed 10-6-03; 8:45 am]
BILLING CODE 4160-01-S