[Federal Register Volume 65, Number 178 (Wednesday, September 13, 2000)]
[Notices]
[Pages 55262-55264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23479]



[[Page 55262]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1283]


Agency Information Collection Activities; Submission for OMB 
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: Submit written comments on the collection of information by 
October 13, 2000.

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, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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; 21 CFR Parts 1002, 1010, 1020, 1030, 1040, and 
1050; FDA Forms 2579, 2767, 2877, and 3147 (OMB Control No. 0910-
0025)--Extension

    Under sections 532 through 542 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360ii through ss), 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 the Code of Federal Regulations, title 21, 
chapter I, subchapter J. Specifically, subchapter A regulations, 21 CFR 
5.10(a)(3), 5.25(b), 5.35(a)(1), and 5.86 through 5.92, 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 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: (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 5, 2000 (65 FR 35648), the agency 
requested comments on the proposed collection of information. The 
following is a summary of the comments and the agency's responses to 
them.
    One comment asked for elimination of reporting requirements and 
enforcement of field surveillance. The comment stated that current 
reporting requirements are excessive and unnecessary and not in line 
with international trend. It was suggested that a ``Supplier's 
Declaration of Conformity'' to the emission standards would be 
sufficient. Manufacturers and importers could provide FDA with 
information required in the current reporting requirements upon 
request.
    FDA was not persuaded by this comment. Reports and field 
surveillance are needed to ensure that product complies with Federal 
performance standards. FDA is in the process of re-engineering the 
Radiological Health Program and is looking into ways of trying to help 
alleviate some of the burden. FDA is currently reviewing its reporting 
requirements and is considering exemption from reporting for certain 
products and electronic filing for others. The comment will be taken 
into consideration.
    One comment requested that Class I laser products containing Class 
I lasers should be excluded from the reporting requirements and a 
declaration be added to the import Form FDA 2877 stating that the 
products are compliant products. This would eliminate the need for an 
accession number.
    FDA partially agrees with this suggestion and has already exempted 
manufacturers who have previously submitted reports from reporting new 
Class I products (those to which access to laser radiation in excess of 
Class I during operation, maintenance, service, and single failure has 
been limited). At this time, there is no way to distinguish these types 
of Class I products from other Class I products through either tariff 
codes or data base product codes.

[[Page 55263]]

FDA is considering different options to help alleviate the problem 
other than adding a new declaration to the form. During the re-
engineering process, FDA will take into account the suggestion.
    One comment stated that FDA's import requirements are outdated and 
most of the information requested for every entry is redundant. FDA can 
simplify the import clearance process by limiting data fields and 
cross-referencing data bases. Also, the import Form FDA 2877 does not 
take into account multiple regulated products that can be included on 
an entry.
    FDA disagrees with the comment that import requirements are 
outdated and most of the information requested for entries is 
redundant. Some data elements on the Form FDA 2877 are required by 
Customs and also assist FDA in limiting the scope of import detentions 
or import review. For example, some countries may have a problem while 
other countries do not, or some product types may have a higher 
surveillance rate due to a non-compliance problem. By obtaining such 
data FDA can better target those shipments that need to be detained for 
investigation and thus permit more shipments to proceed unhindered.
    FDA agrees that the process can be simplified but cannot cross-
reference data between data bases at this time because data bases are 
very different. Budget allocation and several years' effort will be 
required to update the data bases.
    FDA agrees that the import Form FDA 2877 does not take into account 
multiple regulated products that are included on an entry. If the 
information does not fit in the box provided on the form a list may be 
attached.
    One comment stated that the name and address of manufacturing site 
and country of origin creates confidentiality concerns for the 
manufacturer of record.
    FDA was not persuaded by this comment. While FDA appreciates the 
unique situation to manufacturers this information is required by 
Customs and assists FDA in targeting certain areas where there is a 
need to monitor certain products. FDA will continue to explore methods 
to reduce informational requirements while maintaining FDA's ability to 
detain and refuse violative products.
    One comment recommended that a new declaration be added to the Form 
FDA 2877 reflecting the May 14, 1997, notice to industry regarding 
importation of non-compliant products intended for testing and 
evaluation during the design and development stage instead of the 
importer having to use declaration C.
    FDA disagrees with this comment. Currently there is a declaration 
(A6) that takes into account the notice. The notice is intended for 
certain types of non-compliant products. Declaration C should be used 
for products that are not listed in that notice.
    Three comments proposed electronic filing of radiation reports to 
minimize the burden of the collection of information and enhance the 
quality, utility, and clarity of information to be collected.
    FDA agrees with this comment and is currently working on this 
process. FDA must accept electronic submissions by September 2003.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
 21 CFR section    FDA form No.       No. of      frequency  per   Total  annual    Hours  per     Total  hours
                                    respondents       response       responses       response
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1002.3                                 10               1              10              12             120
1002.10 and                           540               1.6           850              24          20,400
 1010.3
1002.11                             1,000               1.5         1,500               0.5           750
1002.12                               150               1             150               5             750
1002.13 (annual)                      900               1             900              26          23,400
1002.13                               250               2.4           600               0.5           300
 (quarterly)
1002.20                                40               1              40               2              80
1002.50(a) and                         10               1.5            15               1              15
 1002.51
                     2877             600              32          19,200               0.2         3,840
1010.2                                  1               1               1               5               5
1010.4(b)                               1               1               1             120             120
1010.5 and                              3               1               3              22              66
 1010.13
                     2767             145              11.03        1,600               0.09          144
1020.20(c)(4)                           1               1               1               1               1
1020.30(d),          2579           2,345               8.96       21,000               0.30        6,300
 (d)(1), and
 (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)
 and
 1020.32(a)(1)
 and (g)
1020.32(g) and                          9               1               9              40             360
 1020.33(c),
 (d), (g)(4),
 (j)(1), and
 (j)(2)
1020.40(c)(9)(i)                        8               1               8              40             320
 and (c)(9)(ii)
1030.10(c)(4)                          41               1.61           66              20           1,320
1030.10(c)(5)(i)                       41               1.61           66              20           1,320
 through
 (c)(5)(iv)
1030.10(c)(6)(ii                        1               1               1               1               1
 i) and
 (c)(6)(iv)
1040.10(a)(3)(i)                       83               1              83               3             249
1040.10(h)(1)(i)                      805               1             805               8           6,440
 through
 (h)(1)(vi)
1040.10(h)(2)(i)                      100               1             100               8             800
 and (h)(2)(ii)
1040.11(a)(2)                         190               1             190              10           1,900
1040.11(c)           3147              53               2.2           115               0.5            58
1040.20(d),                           110               1             110              10           1,100
 (e)(1), and
 (e)(2)
1040.30(c)(1)                           1               1               1               1               1
1040.30(c)(2)                           7               1               7               1               7
1050.10(f)(1)                          10               1              10              56             560
 through
 (f)(2)(iii)
Total                                                                                             89,278
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 55264]]


                               Table 2.--Estimated Annual Recordkeeping Burden \1\
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                                                  Annual
       21 CFR section             No. of       frequency  of     Total  annual      Hours  per      Total hours
                               recordkeepers   recordkeeping        records           record
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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
1002.30(g)(2)                      22               1                22                 0.5            11
1040.10(a)(3)(ii)                  83               1                83                 1              83
Total                                                                                             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 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); 
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)). 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 (5 CFR 
1320.3(c)(2)): Sections 1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 
1040.30(c)(1), and 1050.10(d)(1).

    Dated: September 7, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-23479 Filed 9-12-00; 8:45 am]
BILLING CODE 4160-01-F