[Federal Register: January 23, 2003 (Volume 68, Number 15)]


[Page 3260-3261]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]




Food and Drug Administration

[Docket No. 03N-0009]


Agency Information Collection Activities; Proposed Collection; 

Comment Request; Application for Exemption From Federal Preemption of 

State and Local Medical Device Requirements

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 extension of an existing collection of 

information, and to allow 60 days for public comment in response to the 

notice. This notice solicits comments on FDA's requirements for State 

and local governments' applications for exemption from preemption for 

medical device requirements.

DATES: Submit written or electronic comments on the collection of 

information by March 24, 2003.

ADDRESSES: Submit electronic comments on the collection of information 

to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 

Submit written comments on the collection of information to the Dockets 

Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 

with the docket number found in brackets in the heading of this 


FOR FURTHER INFORMATION CONTACT: Peggy Robbins, 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

[[Page 3261]]

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 extension 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 set forth in this document.

    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.

Application for Exemption From Federal Preemption of State and Local 

Medical Device Requirements--21 CFR Part 808 (OMB Control No. 0910-


    Section 521(a) of the Federal Food, Drug, and Cosmetic Act (the 

act) (21 U.S.C. 360k(a)) provides that no State or local government may 

establish, or continue in effect, any requirement with respect to a 

medical device that is different from, or in addition to, any Federal 

requirement applicable to the device under the act. Under section 

521(b) of the act, following receipt of a written application from the 

State or local government involved, FDA may exempt from preemption a 

requirement that is more stringent than the Federal requirement, or 

that is necessitated by compelling local conditions and compliance with 

the requirement would not cause the device to be in violation of any 

portion of any requirement under the act. Exemptions are granted by 

regulation issued after notice and opportunity for an oral hearing.

    The regulations in 21 CFR 808.20 require a State or local 

government that is seeking an exemption from preemption to submit an 

application to FDA. The application must include a copy of the State or 

local requirement, as well as information about its interpretation and 

application, and a statement as to why the applicant believes that the 

requirement qualifies for exemption from preemption under the act. FDA 

will use the information in the application to determine whether the 

requirement meets the criteria for exemption in the act and whether 

granting an exemption would be in the interest of the public health.

    In addition, 21 CFR 808.25 provides that an interested person may 

request a hearing on an application by submitting a letter to FDA 

following the publication by FDA of a proposed response to the 


    FDA estimates the burden of this collection of information as 


                                 Table 1.--Estimated Annual Reporting Burden\1\


                         No. of        Annual Frequency     Total Annual        Hours per

 21 CFR  Section      Respondents        per Response        Responses           Response         Total  Hours


808.20                             3                  1                  3                100                300


808.25                             3                  1                  3                 10                 30


TOTAL                                                                                                        330


\1\ There are no capital costs or operating and maintenance costs associated with this collection of


    FDA based its estimates of the number of submissions expected in 

the future contained in table 1 of this document on the number of 

submissions submitted in the last 3 years and on the number of 

inquiries received indicating that applications would be submitted in 

the next year. FDA based its estimates of the time required to prepare 

submissions on discussions with those who have prepared submissions in 

the last 3 years.

    Dated: January 14, 2003.

Margaret M. Dotzel,

Assistant Commissioner for Policy.

[FR Doc. 03-1435 Filed 1-22-03; 8:45 am]