[Federal Register Volume 63, Number 193 (Tuesday, October 6, 1998)]
[Notices]
[Pages 53677-53679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0364]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Reporting and Recordkeeping for Electronic 
Products: Specific Product Requirements

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 
November 5, 1998.
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: 
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. 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 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 for Electronic Products: Specific 
Product Requirements (21 CFR Parts 1020, 1030, 1040, and 1050) (OMB 
Control Number 0910-0213)--Reinstatement

    Under sections 532 to 542 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360ii to 360ss), FDA has the responsibility to 
protect the public from unnecessary exposure to

[[Page 53678]]

radiation from electronic products. 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 designed to protect the public health and safety from 
electronic radiation by, among other things, developing and 
administering performance standards for 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 directs the Secretary to immediately notify manufacturers of, 
and assure correction of, radiation defects or noncompliance with 
performance standards. The agency's authority to require records and 
reports is contained in section 537(b) and (c) of the act.
    Under this authority, FDA issued regulations detailing 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 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. 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.
    The consequence of not obtaining the required information is that 
the public unknowingly may be exposed to unnecessary radiation hazards 
presented by electronic products. Without this information, FDA could 
not adequately make rational decisions and take appropriate actions to 
protect the public from these hazards as called for in the act.
    Respondents to this collection of information are manufacturers, 
importers, and assemblers of electronic products. Not all of the 
requirements are placed on all of these groups.
    In the Federal Register of June 22, 1998 (63 FR 33933), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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1020.20(c)(4)                           1               1               1               1               1
1020.30(g)                            200               1.33          265              35           9,275
1020.30(h)(1) through (h)(4) and
 1020.32(a)(1) and (g)\2\             200               1.33          265              35           9,275
1020.32(g) and 1020.33(c), (d),
 (g)(4), (j)(1), and (j)(2)\2\          9               1.00            9              40             360
1020.40(c)(9)(i) and (c)(9)(ii)         8               1.00            8              40             320
1030.10(c)(4)                          41               1.61           66              20           1,320
1030.10(c)(5)(i) through
 (c)(5)(iv)\2\                         41               1.61           66              20           1,320
1040.10(h)(1)(i) through
 (h)(1)(iv)                           805               1.00          805               8           6,440
1040.10(h)(2)(i) and
 (h)(2)(ii)\2\                        100               1.00          100               8             800
1040.11(a)(2)\2\                      190               1.00          190              10           1,900
1040.20(d)(1), (d)(2), (e)(1),
 and (e)(2)                           110               1.00          110              10           1,100
1040.30(c)(1)                           1               1.00            1               1               1
1040.30(c)(2)                           7               1               7               1               7
1050.10(f)(1) and (f)(2)(i)
 through (f)(2)(iii)                   10               1.00           10              56             560
Disclosure Subtotal                 1,176                           1,186                          32,679
1020.30(d)(1) and (d)(2) and
 Form FDA 2579                      2,345               8.96       21,000                .30        6,300
1030.10(c)(6)(iii)                      1               1.00            1               1               1
1030.10(c)(6)(iv)                       1               1.00            1               1               1
1040.10(a)(3)(i)                       83               1.00           83               3             249
1040.10(i)--burden in 1002.10
 (0910-0025)                            0                               0               0               0
Reports Subtotal                    2,430                          21,085                           6,551
Total Annual Reporting Burden       3,606               6.37       22,981               1.71       39,230
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The total number of respondents in the reporting burden, table 1, include respondents who have already been
  included as a subset of another group in the table. The number of firms marked by this superscript have been
  included and counted as a subset of the total firms subject to reporting burden. Therefore, the number of
  firms represented by this superscript have not been added to the total number of respondents on the entry for
  ``Disclosure Subtotal,'' and are not included in the total listed on the last entry of the reporting burden
  table entitled ``Total Annual Reporting Burden.'' However, any hours of burden generated by these firms were
  added to the total reporting burden hours on both the disclosure subtotal and total lines of the reporting
  burden table.


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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1020.30(g)(2)                          22               1              22               0.5            11
1040.10(a)(3)(ii)                      83               1              83               1              83
Total Annual Recordkeeping
 Burden                                                                                                94
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 53679]]

    Due to a typographical error, 21 CFR 1040.30(c)(2) was incorrectly 
placed in table 2 of FDA's previous notice seeking comment on this 
collection of information (63 FR 33933, June 22, 1998). The citation 
has been place in table 1 of this notice and the burden adjusted 
accordingly.
    Certain labeling requirements included in these regulations are 
either exempt from the definition of ``collection of information'' 
under 5 CFR 1320.3(c)(2) because they are ``public disclosure[s] of 
information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public'' or have 
negligible burden. For example, 21 CFR 1040.10(g) states that ``in 
addition to the requirements of Secs. 1010.2 and 1010.3, each laser 
product shall be subject to the applicable labeling requirements of 
this paragraph.'' The provision goes on to require several cautionary 
statements in the labeling of laser products approved under this 
regulation, and further specifies the wording, placement, and label 
design of the required labeling.
    Labeling requirements which are exempt from OMB are 21 CFR 
1040.30(c)(1), 1050.10(d)(1) through (d)(5), and 1020.10(c)(4).
    The burden hour and cost estimates were derived by consultation 
with FDA and industry personnel. 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 .

    Dated: September 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-26647 Filed 10-5-98; 8:45 am]
BILLING CODE 4160-01-F