[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45665-45667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0496]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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: Submit written comments on the collection of information by 
September 29, 1997.
ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, 
Attention: Desk Officer for FDA.

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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance:

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 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360ii through 360ss) 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 (21 U.S.C. 360kk(g)) directs the Secretary to review and 
evaluate industry testing programs on a continuing basis, and section 
535(e) and (f) of the act (21 U.S.C. 360ll(e) and (f)) directs 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 (21 U.S.C. 360nn(b) and (c)).
    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 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 
and to 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.

[[Page 45666]]

    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 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:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                  Annual                                                        Total Operating 
   21 CFR         No. of       Frequency per   Total Annual      Hours per      Total Hours     and Maintenance 
   Section      Respondents      Response        Responses       Response                            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.                                                     


                                 Table 2.--Estimated Annual Recordkeeping Burden                                
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                              Annual                                                            Total Operating 
 21 CFR       No. of       Frequency per     Total Annual        Hours per      Total Hours     and Maintenance 
 Section   Recordkeepers   Recordkeeping        Records        Recordkeeper                          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) through (c), 1003.11(a)(3), 1003.11(b), 
1003.20(a)

[[Page 45667]]

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: August 20, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-22857 Filed 8-27-97; 8:45 am]
BILLING CODE 4160-01-F