[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Burden<SUP>1                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
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       
----------------------------------------------------------------------------------------------------------------
\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 Burden<SUP>1                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
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       
----------------------------------------------------------------------------------------------------------------
\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