Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Devices; Device Tracking, 10648-10650 [05-4161]

Download as PDF 10648 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices In 2001, when preparing the earlier package for approval of the information collection requirements in part 806, FDA reviewed the reports of corrections and removals submitted in the previous 3 years under part 7 (21 CFR part 7) (the agency’s recall provisions). FDA has determined that estimates of the reporting burden in §§ 806.10 and 806.20 should be revised to reflect a reduction of 29 percent for reports and records submitted under part 7 due to a decrease in recall actions. The time needed to collect information has been reduced by 4 hours per record due to the implementation of a computerized program for information collection requirements in part 806. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4159 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0401] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 4, 2005. OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. 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. ADDRESSES: Customer/Partner Service Surveys— (OMB Control Number 0910–0360)— Extension Under section 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393), FDA is authorized to conduct research and public information programs about regulated products and responsibilities of the agency. Executive Order 12862, entitled ‘‘Setting Customer Service Standard,’’ directs Federal agencies that ‘‘provide significant services directly to the public’’ to ‘‘survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services.’’ FDA is seeking OMB clearance to conduct a series of surveys to implement Executive Order 12862. Participation in the surveys is voluntary. This request covers customer/partner service surveys of regulated entities, such as the following: Food processors; cosmetic drug, biologic and medical device manufacturers; consumers; and health professionals. The request also covers ‘‘partner’’ (State and local governments) customer service surveys. FDA will use the information from these surveys to identify strengths and weaknesses in service to customers/ partners and to make improvements. The surveys will measure timeliness, appropriateness and accuracy of information, courtesy, and problem resolution in the context of individual programs. FDA projects that approximately 15 customer/partner service surveys will be conducted per year, with a sample of between 50 and 6,000 customers, requiring an average of 18 minutes for review and completion for each survey. Some of these surveys will be repeats of earlier surveys, for purposes of monitoring customer/partner service and developing long-term data. In the Federal Register of September 16, 2004 (69 FR 55823), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Type of Survey No. of Respondents Mail/telephone/fax/web-based 1There Annual Frequency per Response 15,000 Total Annual Responses 1 15,000 Hours per Respondent .30 Total Hours 4,500 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4160 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0498] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS. ACTION: VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Notice. Frm 00058 Fmt 4703 Sfmt 4703 SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 4, 2005. OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on ADDRESSES: E:\FR\FM\04MRN1.SGM 04MRN1 10649 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (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. Medical Devices; Device Tracking— 21 CFR Part 821 (OMB Control Number 0910–0442)—Extension Section 211 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105–115) became effective on February 19, 1998. It amended the previous medical device tracking provisions in section 519(e)(1) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i(e)(1) and (e)(2) that were added by the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101–629). Unlike the tracking provisions under SMDA, possessing the devices, to the extent that patients permit the collection of identifying information. Manufacturers and, as necessary, FDA use the data to expedite the recall of distributed devices that are dangerous or defective, and to facilitate the timely notification of patients or licensed practitioners of the risks associated with the devices. Respondents to this collection of information are manufacturers, importers, and distributors of tracked implants or tracked l/s-l/s devices used outside a device user facility. Distributors include multiple and final distributors, including hospitals. The regulations include requirements for exemptions and variances; system and content requirements of tracking; obligations of persons other than device manufacturers, e.g., distributors; records and inspection requirements; confidentiality; and record retention requirements. In the Federal Register of November 30, 2004 (69 FR 69604), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: which required tracking for any device meeting certain criteria, FDAMA allows FDA discretion in applying tracking requirements to devices that meet certain criteria and provides that tracking requirements can be imposed only after FDA issues an order. In the Federal Register of February 8, 2002 (67 FR 5943), FDA issued a final rule to conform existing tracking regulations to changes in tracking provisions effected by FDAMA (part 821 (21 CFR part 821)). Current section 519(e)(1) of the act, as amended by FDAMA, provides that FDA may by order require a manufacturer to adopt a method of tracking a class II or class III device, if the device meets one of three criteria: (1) The failure of the device would be reasonably likely to have serious adverse health consequences; (2) the device is intended to be implanted in the human body for more than 1 year (referred to as a ‘‘tracked implant’’); or (3) the device is life-sustaining or lifesupporting (referred to as a ‘‘tracked l/ s-l/s device’’) and is used outside a device user facility. Tracking information is collected to facilitate identifying the current location of tracked devices and patients TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 821.2 (also 821.30(e)) 4 1 4 12 48 821.25(a) 1 1 1 76 76 821.25(d) 22 1 22 2 44 17,000 72 1,222,725 1 1 1 17,000 15 259,186 821.30(a) and (b) 821.30(c)(2) 821.30(d) 0.1666 28 0.1666 Total 1 There 203,706 28 43,180 247,082 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section Annual Frequency per Recordkeeping Total Annual Records 821.25(b) 229 46,260 10,593,433 821.25(c) 229 1 229 821.25(c)(3) 229 1,124 Hours per Recordkeeper 0.2899 257,454 63.0 0.2899 Total 1 There Total Hours 3,071,036 14,430 74,636 3,160,102 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 10650 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices The annual reporting burden hours to respondents for medical device tracking is estimated to be 247,082 hours, and recordkeeping burdens for respondents is estimated to be 3,160,102 hours. These numbers have been rounded up. The estimates cited in tables 1 and 2 of this document are based primarily upon the data and methods provided in FDA’s 1999 assessment entitled ‘‘A Cost Assessment of Medical Device Tracking.’’ Using implantation procedures from the National Center for Health Statistics, FDA applied a 2 percent annual growth rate to estimate the number of procedures for tracked implant devices from 1997–2006. The assessment also used unit shipment data in combination with various growth rates to estimate annual/sales distribution for the tracked l/s-l/s devices over the same time period. Additionally, the assessment estimates the industry burden for developing and maintaining tracking systems for these devices from 1997–2006. For the annual recordkeeping burden, the number of manufacturers subject to device tracking (229) is based on data from FDA’s manufacturers database. FDA issued tracking orders to 20 additional manufacturers during the time period 2002–2004. Under § 821.25(c), the additional manufacturers collectively bear a onetime burden of 10,560 hours to develop a device tracking system. FDA’s estimate of 17,000 distributor respondents contained in the assessment is derived from Dun & Bradstreet sources on medical equipment wholesalers, retailers, home care dealers, and rental companies. Health Forum, an American Hospital Association Co., provided statistics on hospitals. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4161 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1903. SUPPLEMENTARY INFORMATION: I. Background The Department of Health and Human [Docket No. 2005N–0065] Services Healthy People 2010 is a Risk Assessment of the Public Health comprehensive set of disease prevention Impact from Foodborne Listeria and health promotion objectives for the Monocytogenes in Smoked Finfish; Nation to achieve over the first decade of the new century. Created by scientists and Evaluation of Food Code both inside and outside of Government, Provisions That Address Preventive Controls for Listeria Monocytogenes in it identifies a wide range of public health priorities and specific, Retail and Foodservice measurable objectives. One of these Establishments; Request for objectives calls on Federal food safety Comments and for Scientific Data and agencies to reduce foodborne listeriosis Information (Ref. 1). In support of this goal, in 2003, AGENCY: Food and Drug Administration, FDA issued an assessment of the HHS. relative risk to the public health from ACTION: Notice; request for comments foodborne L. monocytogenes among and for scientific data and information. selected categories of RTE foods (Listeria risk assessment) (Ref. 2). The SUMMARY: The Food and Drug Listeria risk assessment formed the basis Administration (FDA) is requesting of the 2003 FDA/CDC Listeria Action comments and scientific data and Plan (Ref. 3), which identifies information that would assist the agency prevention and control activities that in its plans to conduct a risk assessment FDA and CDC will take to reduce the for Listeria monocytogenes in smoked incidence of foodborne listeriosis in the finfish (smoked finfish risk assessment), United States. The smoked finfish risk and evaluate the provisions of the 2001 assessment and the evaluation of the Food Code that address preventive Food Code (Ref. 4) provisions for controls for L. monocytogenes in retail preventive controls for L. and foodservice establishments. The monocytogenes in retail and foodservice purpose of the smoked finfish risk establishments are two of these assessment is to ascertain the impact on prevention and control activities that public health from the reduction and/or support the agency’s commitment to prevention of L. monocytogenes growth fulfilling the Listeria Action Plan. and recontamination during the Smoked Finfish Risk Assessment: The manufacturing and/or processing of hot- 2003 Listeria risk assessment used data and cold-smoked finfish. The smoked on food contamination at retail, the finfish risk assessment and the ability of the food to support growth, evaluation of the Food Code provisions and the impact of home storage time for preventive controls for L. and temperature to estimate the monocytogenes in retail and foodservice likelihood of a type of food to cause establishments support the agency’s listeriosis. The Listeria risk assessment commitment to the Listeria Action Plan determined that smoked seafood has a (revised 2003) that FDA and the Centers relatively high rate of contamination for Disease Control and Prevention and a high predicted per serving relative (CDC) developed to reduce L. risk, yet a lower per annum risk because monocytogenes illnesses associated with it is generally consumed only occasionally in small quantities and/or the consumption of ready-to-eat (RTE) eaten by a relatively small portion of the foods. population. DATES: Submit comments and scientific As a followup to the Listeria risk data and information by May 3, 2005. assessment, the smoked finfish risk ADDRESSES: Submit written comments assessment model will evaluate the and scientific data and information to sources of contamination, how the Division of Dockets Management individual steps in manufacturing and/ (HFA–305), Food and Drug or processing contribute to Administration, 5630 Fishers Lane, rm. contamination, and the effectiveness of 1061, Rockville, MD 20852. Submit various preventative strategies. The electronic comments, data, and objectives of the smoked finfish risk information to http://www.fda.gov/ assessment are to evaluate the impact on dockets/ecomments. public health from the reduction/ prevention of the following: (1) L. FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food Safety monocytogenes growth during the manufacturing and/or processing of and Applied Nutrition (HFS–06), Food smoked finfish, (2) L. monocytogenes and Drug Administration, rm. 2B–023, PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10648-10650]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4161]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0498]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Medical Devices; Device Tracking

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
4, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on

[[Page 10649]]

the information collection are received, OMB recommends that comments 
be faxed to the Office of Information and Regulatory Affairs, OMB, 
Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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.
    Medical Devices; Device Tracking--21 CFR Part 821 (OMB Control 
Number 0910-0442)--Extension
    Section 211 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) became effective on February 19, 
1998. It amended the previous medical device tracking provisions in 
section 519(e)(1) and (e)(2) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360i(e)(1) and (e)(2) that were added by the 
Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629). Unlike 
the tracking provisions under SMDA, which required tracking for any 
device meeting certain criteria, FDAMA allows FDA discretion in 
applying tracking requirements to devices that meet certain criteria 
and provides that tracking requirements can be imposed only after FDA 
issues an order. In the Federal Register of February 8, 2002 (67 FR 
5943), FDA issued a final rule to conform existing tracking regulations 
to changes in tracking provisions effected by FDAMA (part 821 (21 CFR 
part 821)).
    Current section 519(e)(1) of the act, as amended by FDAMA, provides 
that FDA may by order require a manufacturer to adopt a method of 
tracking a class II or class III device, if the device meets one of 
three criteria: (1) The failure of the device would be reasonably 
likely to have serious adverse health consequences; (2) the device is 
intended to be implanted in the human body for more than 1 year 
(referred to as a ``tracked implant''); or (3) the device is life-
sustaining or life-supporting (referred to as a ``tracked l/s-l/s 
device'') and is used outside a device user facility.
    Tracking information is collected to facilitate identifying the 
current location of tracked devices and patients possessing the 
devices, to the extent that patients permit the collection of 
identifying information. Manufacturers and, as necessary, FDA use the 
data to expedite the recall of distributed devices that are dangerous 
or defective, and to facilitate the timely notification of patients or 
licensed practitioners of the risks associated with the devices.
    Respondents to this collection of information are manufacturers, 
importers, and distributors of tracked implants or tracked l/s-l/s 
devices used outside a device user facility. Distributors include 
multiple and final distributors, including hospitals.
    The regulations include requirements for exemptions and variances; 
system and content requirements of tracking; obligations of persons 
other than device manufacturers, e.g., distributors; records and 
inspection requirements; confidentiality; and record retention 
requirements.
    In the Federal Register of November 30, 2004 (69 FR 69604), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 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
----------------------------------------------------------------------------------------------------------------
821.2 (also                       4                  1                  4             12                      48
 821.30(e))
----------------------------------------------------------------------------------------------------------------
821.25(a)                         1                  1                  1             76                      76
----------------------------------------------------------------------------------------------------------------
821.25(d)                        22                  1                 22              2                      44
----------------------------------------------------------------------------------------------------------------
821.30(a) and                17,000                 72          1,222,725              0.1666            203,706
 (b)
----------------------------------------------------------------------------------------------------------------
821.30(c)(2)                      1                  1                  1             28                      28
----------------------------------------------------------------------------------------------------------------
821.30(d)                    17,000                 15            259,186              0.1666             43,180
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    247,082
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               TABLE 2.--ESTIMATED ANNUAL RECORDKEEPING BURDEN\1\
----------------------------------------------------------------------------------------------------------------
                                      Annual Frequency
 21 CFR Section         No. of              per            Total Annual         Hours per         Total Hours
                    Recordkeepers      Recordkeeping         Records          Recordkeeper
----------------------------------------------------------------------------------------------------------------
821.25(b)                       229             46,260         10,593,433              0.2899          3,071,036
----------------------------------------------------------------------------------------------------------------
821.25(c)                       229                  1                229             63.0                14,430
----------------------------------------------------------------------------------------------------------------
821.25(c)(3)                    229              1,124            257,454              0.2899             74,636
----------------------------------------------------------------------------------------------------------------
Total                                                                                                  3,160,102
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 10650]]

    The annual reporting burden hours to respondents for medical device 
tracking is estimated to be 247,082 hours, and recordkeeping burdens 
for respondents is estimated to be 3,160,102 hours. These numbers have 
been rounded up. The estimates cited in tables 1 and 2 of this document 
are based primarily upon the data and methods provided in FDA's 1999 
assessment entitled ``A Cost Assessment of Medical Device Tracking.'' 
Using implantation procedures from the National Center for Health 
Statistics, FDA applied a 2 percent annual growth rate to estimate the 
number of procedures for tracked implant devices from 1997-2006. The 
assessment also used unit shipment data in combination with various 
growth rates to estimate annual/sales distribution for the tracked l/s-
l/s devices over the same time period. Additionally, the assessment 
estimates the industry burden for developing and maintaining tracking 
systems for these devices from 1997-2006.
    For the annual recordkeeping burden, the number of manufacturers 
subject to device tracking (229) is based on data from FDA's 
manufacturers database. FDA issued tracking orders to 20 additional 
manufacturers during the time period 2002-2004. Under Sec.  821.25(c), 
the additional manufacturers collectively bear a one-time burden of 
10,560 hours to develop a device tracking system. FDA's estimate of 
17,000 distributor respondents contained in the assessment is derived 
from Dun & Bradstreet sources on medical equipment wholesalers, 
retailers, home care dealers, and rental companies. Health Forum, an 
American Hospital Association Co., provided statistics on hospitals.

    Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4161 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S