Agency Information Collection Activities: Proposed Collection; Comment Request, 18035-18036 [05-7018]

Download as PDF 18035 Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices instance of potential health-endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has entered distribution in commerce (§§ 108.25(d) and 108.35(d) and (e)); and to develop and keep on file plans for recalling products that may endanger the public health (§§ 108.25(e) and 108.35(f)). To permit lots to be traced after distribution, acidified foods and thermally processed low-acid foods in hermetically sealed containers must be marked with an identifying code (§§ 113.60(c) (thermally processed foods) and 114.80(b) (acidified foods)). In the Federal Register of February 7, 2005 (70 FR 6445), FDA published a 60day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of the collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Form No. 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response FDA 2541 (registration) 108.25 and 108.35 585 1 585 FDA 2541a (process filing) 108.25 and 108.35 1,778 9 16,002 0.333 FDA 2541(c) 108.35 124 10 1,240 0.75 0.17 Total 1 There Total Hours 99 5,329 930 6,358 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 Part Parts 113 and 114 1 There Annual Frequency per Record 7,915 Total Annual Records 1 Hours per Recordkeeper 7,915 250 Total Hours 1,978,750 are no capital costs or operating and maintenance costs associated with this collection of information. The reporting burden for §§ 108.25(d) and 108.35(d) and (e) is insignificant because notification of spoilage, process deviation, or contamination of product in distribution occurs less than once a year. Most firms discover these problems before the product is distributed and, therefore, are not required to report the occurrence. To avoid double-counting, estimates for §§ 108.25(g) and 108.35(h) have not been included because they merely cross reference recordkeeping requirements contained in parts 113 and 114. There are approximately 7,915 food processing establishments, both foreign and domestic, registered as processors of acidified foods or thermally processed low-acid foods in hermetically sealed containers. Four FDA staff persons who are experienced in actual food processing plant operations and familiar with the regulations reviewed the recordkeeping procedures used by the industry. Standardized timeframe requirements for conducting the recordkeeping procedures do not exist but it is estimated to take 250 hours per establishment to comply with the recordkeeping requirements in parts 108, 113, and 114. This compares satisfactorily when based upon firsthand food processing plant experience, individual estimates of the VerDate jul<14>2003 19:00 Apr 07, 2005 Jkt 205001 timeframes, and the frequency of recordkeeping. Dated: April 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–7028 Filed 4–7–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer at (301) 443–1129. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Division of Perinatal Systems and Women’s Health—Forms for the Guidance for Healthy Start Program Application and Other Reports—New The Application Guidance for grants within the Division of Healthy Start and Perinatal Services (DHSPS) is used annually by all community based Healthy Start organizations and agencies applying for funding (either continued or new), and in preparing the required annual report. The guidance provides guidelines to the organizations and agencies on how to apply for Healthy Start funds. Included in the guidance are a number of data collection forms, which are used annually by organizations that have applied for and/ E:\FR\FM\08APN1.SGM 08APN1 18036 Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices or are receiving Healthy Start funding. It is proposed that additional data be collected and reported to provide increased program information. The completion of the new and existing forms by all applicants has an estimated overall burden of 500 hours, or approximately five (5) hours per respondent. The burden estimate for this activity is based upon information provided by current and past funded Healthy Start grantees, as well as previous experience in completing the current forms. The estimated response burden is as follows: Application and annual report Estimated number of respondents Responses per respondent Burden hours per response Total burden hours Community Based Organizations and Agencies ............................................. 100 1 5 500 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of notice. Dated: April 1, 2005. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. 05–7018 Filed 4–7–05; 8:45 am] SUPPLEMENTARY INFORMATION: Background BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration HHS Approval of Professional Organizations and States’ Standards for Certification Health Resources and Services Administration, HHS. AGENCY: ACTION: Solicitation of comments. SUMMARY: The Health Resources and Services Administration’s (HRSA) Healthcare Systems Bureau, Division of Healthcare Preparedness Poison Control Program, provides supplemental funding to Poison Control Centers (PCCs) across the United States, promotes universal access to PCC services, and encourages the enhancement and improvement of poison education, prevention, and treatment. To receive funding from HRSA, PCCs must meet certain certification requirements. The purpose of this solicitation of comments is to assist HRSA in establishing criteria/ guidelines to approve professional organizations and State governments’ certification standards for PCCs. DATES: To be considered, written comments should be postmarked no later than June 7, 2005. ADDRESSES: Please send all comments to HRSA’s Division of Healthcare Preparedness, Healthcare Systems Bureau, Attention: Maxine Jones, Room VerDate jul<14>2003 19:00 Apr 07, 2005 Jkt 205001 13–103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Maxine Jones, HRSA, HSB, Division of Healthcare Preparedness, (301) 443– 6192, fax (301) 443–4922, or e-mail mjones@hrsa.gov. In February 2000, Congress enacted the Poison Control Center Enhancement and Awareness Act, Pub. L. No. 106– 174. This Act authorized funding to establish a national toll-free number to access Poison Control Center (PCC) services, a nationwide poison prevention media campaign, and a grant program to achieve financial stability of PCCs. In addition, the Act directed the Secretary of HHS to: (1) Develop standard education programs; (2) develop standard patient management protocols for commonly encountered exposures; (3) improve and expand the poison control data collection systems; (4) improve national toxic exposure surveillance, and (5) expand the physician/medical toxicologist supervision of PCCs. This Act was amended by Public Law 108–194, the Poison Control Enhancement and Awareness Act Amendments of 2003, which directs the Secretary of HHS to improve the capacity of poison control centers to answer high volumes of calls during times of national crisis, in addition to the activities listed in the original Act. The grant program that was established provides funding for financial stabilization, certification, and incentive grants. Financial stabilization grants assist with financial stabilization and the improvement of services in PCCs that already meet American Association of Poison Control Centers (AAPCC) certification standards. Certification grants assist uncertified centers in efforts to attain certification status in addition to promoting enhancement of services. Incentive grants are awarded to PCCs that are working collaboratively and PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 innovatively to improve poison control systems and services. In general, PCCs must meet the certification requirements listed in Public Law 108–194 sec. 1273(c) to receive funding from HRSA. One way PCCs can fulfill this requirement is if the PCC ‘‘has been certified by a professional organization in the field of poison control, and the Secretary has approved the organization as having in effect standards for certification that reasonably provide for the protection of the public health with respect to poisoning.’’ The second way PCCs can fulfill this requirement is if the PCC ‘‘has been certified by a State government, and the Secretary has approved the State government as having in effect standards for certification that reasonably provide for the protection of the public health with respect to poisoning.’’ (Pub. L. No. 108– 194 sec. 1273(c)). Solicitation of Comments The HRSA is seeking public input regarding guidelines by which the Secretary shall approve professional organizations and State governments as having in effect standards for PCC certification. Respondents are asked to submit recommended guidelines for approving professional organizations and State governments’ standards for certification, per Public Law 108–194 sec. 1273(c). Written comments should be limited to no more than 10 double-spaced pages or 5 single-spaced pages and should contain the name, address, telephone, and fax numbers, and any organizational affiliation of the persons providing written comments. Respondents may be contacted by the Poison Control Program, HRSA, to answer questions regarding their submitted comments. We are particularly interested in comments which address but are not limited to the following issues: 1. Modeling the guidelines after certification requirements that are currently being used to certify PCCs; E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18035-18036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Public Law 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to OMB under the Paperwork Reduction Act 
of 1995. To request more information on the proposed project or to 
obtain a copy of the data collection plans and draft instruments, call 
the HRSA Reports Clearance Officer at (301) 443-1129.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information shall have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: Division of Perinatal Systems and Women's Health--
Forms for the Guidance for Healthy Start Program Application and Other 
Reports--New

    The Application Guidance for grants within the Division of Healthy 
Start and Perinatal Services (DHSPS) is used annually by all community 
based Healthy Start organizations and agencies applying for funding 
(either continued or new), and in preparing the required annual report. 
The guidance provides guidelines to the organizations and agencies on 
how to apply for Healthy Start funds. Included in the guidance are a 
number of data collection forms, which are used annually by 
organizations that have applied for and/

[[Page 18036]]

or are receiving Healthy Start funding. It is proposed that additional 
data be collected and reported to provide increased program 
information. The completion of the new and existing forms by all 
applicants has an estimated overall burden of 500 hours, or 
approximately five (5) hours per respondent. The burden estimate for 
this activity is based upon information provided by current and past 
funded Healthy Start grantees, as well as previous experience in 
completing the current forms.
    The estimated response burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Estimated
        Application and annual report            number of      Responses per     Burden hours     Total burden
                                                respondents       respondent      per response        hours
----------------------------------------------------------------------------------------------------------------
Community Based Organizations and Agencies..             100                1                5              500
----------------------------------------------------------------------------------------------------------------

    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857. Written comments should be received within 60 days of notice.

    Dated: April 1, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-7018 Filed 4-7-05; 8:45 am]
BILLING CODE 4165-15-P