[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