[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Notices]
[Pages 33933-33934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16503]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0364]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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 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 product specific reports and
recordkeeping requirements for certain electronic products.
DATES: Submit written comments on the collection of information by
August 21, 1998.
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: 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: 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 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 radiation from
electronic products. Section 532 of the act (21 U.S.C. 360ii) 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 (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 noncompliance with performance
standards. The agency's authority to require records and reports is
contained in section 537(b) and (c) of the act (21 U.S.C. 360nn(b) and
(c)).
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.
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
[[Page 33934]]
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
1050.10(f)(1) and (f)(2)(i)
through (f)(2)(iii) 10 1.00 10 56 560
Disclosure Subtotal 1,176 1,896 32,672
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) and
(c)(6)(iv) 1 1.00 1 1 1
1030.10(c)(6)(iv) 1 1.00 1 1 1
1040.10(a)(3)(i) 83 1 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 39,223
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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 an asterisk have been
included and counted as a subset of the total firms subject to reporting burden. Therefore, the number of
firms represented by an asterisk 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(q)(2) 22 1 22 0.5 11
1040.10(a)(3)(ii) 83 1 83 1 83
1040.30(c)(2) 7 1 7 1 7
Total Annual Recordkeeping
Burden 101
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
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.
21 CFR 1040.30(c)(1), 1050.10(d)(1) through (d)(5), and
1020.10(c)(4) are labeling requirements which are exempt from OMB.
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: June 11, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-16503 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F
