[Federal Register Volume 62, Number 42 (Tuesday, March 4, 1997)]
[Notices]
[Pages 9793-9795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5211]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0496]
Agency Information Collection Activities: Proposed Collection;
Reinstatement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 a notice in the
Federal Register concerning each proposed collection of information,
including each proposed reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting and
recordkeeping requirements for manufacturers and distributors of
electronic products set forth in the regulations.
DATES: Submit written comments on the collection of information by
April 3, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1479.
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 reinstatement 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 listed below.
With respect to the following collection of information, FDA
invites comments on: (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 for Manufacturers and
Distributors of Electronic Products--21 CFR Parts 1002-1010, FDA
Forms 2877, 3147, and 766 (OMB Control Number 0910-0025--
Reinstatement)
Sections 532 through 542 (21 U.S.C. 360ii through ss) of the
Federal Food, Drug, and Cosmetic Act (the act) direct the Secretary of
the Department of Health and Human Services (the Secretary) to
establish and carry out an electronic product radiation control program
to protect the public from unnecessary radiation from electronic
products. Such program shall include the development, issuance, and
administration of performance standards to control the emission of
electronic product radiation from electronic 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 direct the Secretary to immediately notify manufacturers of,
and assure correction of, radiation defects or noncompliances with
performance standards. The authority for records and reports is
contained in section 537(b) and (c) of the act.
The regulations implementing these statutory provisions are found
in parts 1002 through 1010 (21 CFR parts 1002 through 1010). Section
1002.3 requires manufacturers, when directed by FDA, to provide
technical and safety information to users. Section 1002.10(a) through
(k) requires manufacturers to submit to FDA product reports containing
identification, design, operation and testing, quality control
procedures, test results, and product labeling prior to the entry of
the product into commerce. Section 1002.11(a) and (b) requires
manufacturers to submit supplemental reports to FDA if modifications in
product safety or testing of electronic products affect actual or
potential radiation emission. Section 1002.12(a) through (e) requires
manufacturers to submit abbreviated information on product safety and
testing. Section 1002.13(a) through (c) requires manufacturers to
report annually to FDA a summary of manufacturer records maintained in
accordance with Sec. 1002.30, and provide quarterly updates of models
instead of Sec. 1002.10 or Sec. 1002.11 reports. Section 1002.20(a)
through (c) requires manufacturers to report to FDA the circumstances,
amount of exposure, and
[[Page 9794]]
remedial actions taken concerning any accidental radiation occurrence
involving their electronic products. If a firm is also required to
report the incident under 21 CFR part 803, those regulations take
precedence. Section 1002.30(a) and (b) requires manufacturers to keep
records on test data and procedures, correspondence regarding radiation
safety, and distribution records. Section 1002.31(a) requires
manufacturers to maintain records required to be kept under part 1002
for 5 years. Section 1002.31(c) requires manufacturers, when requested
by FDA, to provide copies of the distribution records required to be
maintained by Sec. 1002.30(b). Section 1002.40(a) through (c) requires
dealers and distributors to retain first purchaser information, to be
used by manufacturers when a product recall is instituted to ensure the
radiation safety of a product. Section 1002.41(a) and (b) specifies
that the dealer/distributor records in Sec. 1002.40 may be retained by
the dealer or forwarded to the manufacturer for retention and that the
manufacturer or dealer shall retain distribution records for 5 years.
Section 1002.50(a) specifies criteria by which manufacturers may
request exemption from reporting and recordkeeping requirements when
there is a low risk of injury, and Sec. 1002.51 specifies criteria by
which manufacturers may request exemption from reporting and
recordkeeping requirements under certain circumstances if the product
is intended for U.S. Government use. The burden is combined with
Sec. 1002.50(a), because the processes and procedures are identical.
Section 1003.10(a) and (c) requires manufacturers to notify FDA
when their product has a defect or fails to comply with applicable
performance standards. Also, under Sec. 1003.10(b) manufacturers must
notify purchasers, dealers, and distributors of product defects or
noncompliance. Section 1003.11(a)(3) specifies criteria by which
manufacturers may refute FDA's notice of defective or noncompliant
product, and Sec. 1003.11(b) states that manufacturers, when notified
by FDA, must provide information on the number of defective products
introduced into commerce. Section 1003.20(a) through (h) specifies
information to be provided by manufacturers to FDA when the
manufacturer discovers a defect or failure to comply. Section
1003.21(a) through (d) specifies the content and format of the
notification by manufacturers to affected persons required by
Sec. 1003.10(a). Under Sec. 1003.22(a) and (b), manufacturers must
provide to FDA copies of the Sec. 1003.10 disclosure sent to
purchasers, dealers or distributors. Section 1003.30(a) and (b)
specifies criteria by which manufacturers may request an exemption from
the Sec. 1003.10 disclosure and possible product recall and
Sec. 1003.31(a) and (b) specifies the content of the Sec. 1003.30
report and the procedure that the agency will follow in reviewing
exemption requests. Sections 1004.2(a) through (i), 1004.3(a) through
(i), and 1004.4(a) through (h) require manufacturers to report to FDA
every plan to remedy a product defect or noncompliance through repair
or replacement or refund.
Section 1005.21(a) through (c) specifies criteria for manufacturers
or importers to request correction of noncompliant products for
importation into the United States, including specific corrections,
timeframe, and location for completion. Such requests are made on Form
FDA 766, Application for Authorization to Relabel or to perform other
action of the Federal Food, Drug, and Cosmetic Act and other related
Acts. Section 1005.25(a) and (b) requires importers to report
identification information and compliance status of products to FDA.
Initial designations are provided in the Secs. 1002.10, 1002.11, and
1002.12 reports, so that burden is included in those sections. For each
shipment, identification is made on Form FDA 2877. Form FDA 2877,
Declaration for Products Subject to Radiation Control Standards, is
used to collect this information.
Part 1010 prescribes performance standards for electronic products,
under section 534 of the act, to which manufacturers must certify.
Section 1010.2(d) specifies criteria for manufacturers to request
alternate means of certification to a performance standard. Section
1010.3(a) through (c) requires manufacturers to provide to FDA the
coding systems if information on labels is coded and to identify each
brand name, and the name and address of the individual or company for
whom each product so branded is manufactured. Because firms provide
such information in the Secs. 1002.10, 1002.11, and 1002.12 reports,
the burden is included in those sections. Section 1010.4(b) specifies
criteria for manufacturers to petition FDA for a variance from a
performance standard. Form FDA 3147, Application for a Variance from 21
CFR 1040.11(c) for Laser Light Shows, is used only by manufacturers of
laser products to submit the information. Since the vast majority of
variances are submitted by this industry, this form was developed to
reduce the burden and timeframe for approvals. Section 1010.5(c) and
(d) specifies criteria by which manufacturers or U.S. Government
agencies may request an exemption (or amendment or extension) from
performance standards when a product is to be used exclusively by a
part of the U.S. Government and has adequate radiation emission
specifications. Section 1010.13 provides that manufacturers may request
alternate test procedures from those specified in a performance
standard. The burden is combined with Sec. 1010.5(c) and (d) because
the processes and procedures are identical.
The information collections are placed upon manufacturers,
importers, assemblers, distributors and dealers of electronic products.
Not all of the requirements are placed on all of these groups. The data
reported to FDA and the records that are 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. The reports
are reviewed by FDA staff to determine product safety and adequacy of
quality control testing. Potential and actual problems are resolved
with the individual firm. Each firm's quality control staff reviews the
test records to maintain production of safe and compliant products. The
data provided to users and others are intended to encourage actions to
reduce or eliminate radiation exposures.
If FDA did not collect this information, FDA may not have
sufficient information to take appropriate actions to protect the
public from unnecessary radiation hazards presented by electronic
products.
FDA estimates the burden of this collection of information as
follows:
[[Page 9795]]
Estimated Annual Reporting Burden
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21 CFR Annual
Section/Form No. of Frequency per Total Annual Hours per Total Hours Total Operating &
Number Respondents Response Responses Response Maintenance Costs
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1002.3 10 1 10 12 120 $2,940
1002.10,
1010.3 540 1.6 850 24 20,400 $499,800
1002.11 1,000 1.5 1,500 0.5 750 $18,375
1002.12 150 1 150 5 750 $18,375
1002.13
Annual 900 1 900 26 23,400 $573,300
1002.13
Quarterly 250 2.4 600 0.5 300 $7,350
1002.20 40 1 40 2 80 $1,960
1002.50(a),
1002.51 10 1.5 15 1 15 $367.50
Form FDA
2877 600 32 19,200 0.2 3,840 $94,080
1010.2 1 1 1 5 5 $122.50
1010.4 and
Form FDA
3147 53 2.1 115 0.5 58 $1,421
1010.4--Othe
r 1 1 1 120 120 $2,940
1010.5,
1010.13 3 1 3 22 66 $1,617
Totals 1,760 23,385 49,904 $1,222,648
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There are no capital costs associated with this collection.
Estimated Annual Recordkeeping Burden
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Annual
21 CFR No. of Frequency per Total Annual Hours per Total Hours Total Operating &
Section Recordkeepers Recordkeeping Records Recordkeeper Maintenance Costs
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1002.30,
1002.31
(a) 1,150 1,655.5 1,903,825 198.7 228,505 $5,598,373
1002.40,
1002.41 2,950 49.2 145,140 2.4 7,080 $173,460
Totals 4,100 235,585
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There are no capital costs associated with this collection.
These burden estimates are based on comments from industry and
interviews with industry personnel.
Several requirements are not included in the burden chart because
they are exempt under 5 CFR 1320.4. These exempt requirements are:
Sections 1002.31(c), 1003.10(a) and (c), 1003.10(b), 1003.11(a)(3),
1003.11(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). Other requirements are not included because they constitute a
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)).
Dated: February 24, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-5211 Filed 3-3-97; 8:45 am]
BILLING CODE 4160-01-F
