Notices. Notice
3,140 words·~14 min read·
/register/2006/01/18/06-423A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6750-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-06-0479] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-4766 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* 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. Written comments should be received within 60 days of this notice. Proposed Project Automated Management Information System
(MIS)for Diabetes Control Programs (OMB No. 0920-0479)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Division of Diabetes Translation
(DDT)within the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC), has implemented a Management Information System
(MIS)and Federally sponsored data collection requirement from all CDC funded Diabetes Prevention and Control Programs. Diabetes is the sixth leading cause of death in the United States contributing to more than 224,000 deaths each year. An estimated 14.6 million people in the United States have been diagnosed with diabetes and an estimated 6.2 million people have undiagnosed diabetes. The Division of Diabetes Translation provides funding to health departments of States and territories to develop, implement, and evaluate systems-based Diabetes Prevention and Control Programs (DPCPs). DPCPs are population-based, public health programs that design, implement and evaluate public health prevention and control strategies that improve access to and quality of care for all, and reach communities most impacted by the burden of diabetes ( *e.g.* , racial/ethnic populations, the elderly, rural dwellers and the economically disadvantaged). Support for these programs is a cornerstone of the DDT's strategy for reducing the burden of diabetes throughout the nation. The Diabetes Control Program is authorized under sections 301 and 317(k) of the Public Health Service Act [42 U.S.C. sections 241 and 247b(k)]. In accordance with the original OMB approval (0920-0479) and the first extension (August 14, 2003) for this project, this requested 3 years OMB revision will continue to expand and enhance the technical reporting capacity of the MIS. MIS is a web-based, password access protected repository/technical reporting system that replaced an archaic paper reporting system. MIS allows the accurate, uniform, and complete collection of diabetes program progress information using the Internet. The number of hours that DPCPs users spend with the system usage has increased since compared to the initial baseline proposed in the last OMB approval three years ago. This increase in burden does not directly translate into a greater reporting burden, but facilitates better monitoring and tracking of their programs and helps create an organizational memory. Consequently, they are using the System to a great extent as an integral part of their program compared to previous years. DPCPs add updates about their work plans and other activities into the System on an ongoing basis. The hour-burden estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Based on input provided by a representative sample for DPCPs, the total annualized response burden increased from 4 to 96 hours, changing the total burden hours from 236 to 5,664. Even though there has been an increase in the burden hours the number of responses remains at one (1), because the DPCPs are only required to report annually to CDC. MIS has improved upon the old data collection system by: • Improving accountability. • Shortening the information cycle. • Eliminating non-standard reporting. • Minimizing unnecessary duplication of data collection and entry. • Reducing the reporting burden on small state organizations. • Using plain, coherent, and unambiguous terminology that is understandable to respondents. • Implementing a consistent system for progress reporting and record keeping processes. • Identifying the retention periods for record keeping requirements. • Utilizing modern information technology for data collection and transfer. • Significantly reducing the amount of paper reports that diabetes prevention and control programs are required to submit. MIS has allowed CDC to more rapidly respond to outside inquiries concerning a specific diabetes control activity occurring in the state diabetes prevention and control programs. The data collection requirement has formalized the format and the content of diabetes data reported from the DPCPs and provides an electronic means for efficient collection and transmission to the CDC headquarters. MIS has facilitated the staff's ability at CDC to fulfill its obligations under the cooperative agreements; to monitor, evaluate, and compare individual programs; and to assess and report aggregate information regarding the overall effectiveness of the DCP program. It has also supported DDT's broader mission of reducing the burden of diabetes by enabling DDT staff to more effectively identify the strengths and weaknesses of individual DPCPs and to disseminate information related to successful public health interventions implemented by these organizations to prevent and control diabetes. Implementation of MIS has provided for efficient collection of state-level diabetes program data. The respondent's average Internet cost is $1,080 per year. Estimated Annualized Burden Table Respondents Number of respondents Number of responses per respondent Average burden per response (in hrs.) Total burden (hours) State Program Control Officers 59 1 96 5664 Dated: January 10, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-442 Filed 1-17-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Advisory Board on Radiation and Worker Health In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following committee meeting: *Correction:* This notice was published in the **Federal Register** on January 3, 2006, volume 71, Number 1, Page 120-121. The meeting times/dates and “matters to be discussed” have been changed. *Subcommittee Meeting Time and Date:* 9 a.m.-2 p.m., January 24, 2006. *Committee Meeting Times and Dates:* 2:30 a.m.-5 p.m., January 24, 2006. 8:30 a.m.-5 p.m., January 25, 2006. 8:30 a.m.-4:30 p.m., January 26, 2006. *Matters to be Discussed:* The agenda for the Subcommittee meeting includes Task 3 review; review of Bethlehem Steel, Rocky Flats, and Y-12 site profiles; and individual dose reconstruction reviews. The agenda for the Board meeting includes Reports from the Subcommittee and Working Groups; Pacific Proving Grounds Special Exposure Cohort
(SEC)Evaluation Report and Supplement; Site Profiles for Bethlehem Steel, Rocky Flats, Y-12, Hanford, Nevada Test Site, and Savannah River Site; Letter from Steel Workers; SEC Rule rewrite; Task 3 review of SC&A Contract; Conflict of Interest issues; Dose Reconstruction Reviews; an update on Science Issues which will include but not be limited to Lymphoma—Dose Reconstruction Target Organ Selection; future schedules; procedures for the Board to use in reviewing SEC petitions (including a discussion of the Y-12 SEC Petition). The evening public comment sessions are scheduled for January 24 from 5:30 p.m.-6:30 p.m. and January 25 from 7 p.m.-8:30 p.m. *For Further Information Contact:* Dr. Lewis V. Wade, Executive Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513-533-6825, fax 513-533-6826. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: January 9, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-436 Filed 1-17-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0494] Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations 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 collections of information in current rules, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions in FDA's cosmetic labeling regulations. FDA's cosmetic labeling regulations, as published in the **Federal Register** on March 15, 1974 (39 FR 10054 at 10056) and subsequently amended, most recently on March 17, 1999 (64 FR 13254 at 13297), remain unchanged by this notice. FDA is publishing this notice in compliance with the PRA. This notice does not represent any new regulatory initiative. DATES: Submit written or electronic comments on the collection of information by March 20, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (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 document. 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: 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 collections of information in current rules, 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. Under section 3506(c)(2)(A) of the PRA and 5 CFR 1320.8(d)(1), 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. Cosmetic Labeling Regulations—(21 CFR Part 701) The Federal Food, Drug, and Cosmetic Act (the act) and the Fair Packaging and Labeling Act (the FPLA) require that cosmetic manufacturers, packers, and distributors disclose information about themselves or their products on the labels or labeling of their products. Sections 201, 502, 601, 602, 603, 701, and 704 of the act (21 U.S.C. 321, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of the FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA to regulate the labeling of cosmetic products. Failure to comply with the requirements for cosmetic labeling may render a cosmetic adulterated under section 601 of the act or misbranded under section 602 of the act. FDA's cosmetic labeling regulations are published in part 701 (21 CFR part 701). Four of the cosmetic labeling regulations have information collection provisions. Section 701.3 requires the label of a cosmetic product to bear a declaration of the ingredients in descending order of predominance. Section 701.11 requires the principal display panel of a cosmetic product to bear a statement of the identity of the product. Section 701.12 requires the label of a cosmetic product to specify the name and place of business of the manufacturer, packer, or distributor. Section 701.13 requires the label of a cosmetic product to declare the net quantity of contents of the product. FDA's cosmetic labeling regulations, as published in the **Federal Register** on March 15, 1974 (39 FR 10054 at 10056) and subsequently amended, most recently on March 17, 1999 (64 FR 13254 at 13297), remain unchanged by this notice. FDA is publishing this notice in compliance with the PRA. This notice does not represent any new regulatory initiative. FDA estimates the annual burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 701.3 1518 21 31,600 1.00 31,600 701.11 1518 24 36,340 1.00 36,340 701.12 1518 24 36,340 1.00 36,340 701.13 1518 24 36,340 1.00 36,340 Total 140,620 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The hour burden is the additional or incremental time that establishments need to design and print labeling that includes the following required elements: A declaration of ingredients in decreasing order of predominance, a statement of the identity of the product, a specification of the name and place of business of the establishment, and a declaration of the net quantity of contents. These requirements increase the time establishments need to design labels because they increase the number of label elements that establishments must take into account when designing labels. These requirements do not generate any recurring burden per label because establishments must already print and affix labels to cosmetic products as part of normal business practices. According to the 2001 census, there are 1,518 cosmetic product establishments in the United States (U.S. Census Bureau, *http://www.census.gov/epcd/susb/2001/us/US32562.HTM* ). FDA calculates label design costs based on stockkeeping units
(SKUs)because each SKU has a unique product label. Based on data available to the agency and on communications with industry, FDA estimates that cosmetic establishments will offer 94,800 SKUs for retail sale in 2005. This corresponds to an average of 62 SKUs per establishment. One of the four provisions that FDA discusses in this information collection, § 701.3, applies only to cosmetic products offered for retail sale. However, the other three provisions, §§ 701.11, 701.12, and 701.13, apply to all cosmetic products, including non-retail professional-use-only products. FDA estimates that including professional-use-only cosmetic products increases the total number of SKUs by 15 percent to 109,020. This corresponds to an average of 72 SKUs per establishment. Finally, based on the agency's experience with other products, FDA estimates that cosmetic establishments may redesign up to one-third of SKUs per year. Therefore, FDA estimates that the annual frequency of response will be 21 (31,600 SKUs) for § 701.3 and 24 each (36,340 SKUs) for §§ 701.11, 701.12, and 701.13. FDA estimates that each of the required label elements may add approximately 1 hour to the label design process. FDA bases this estimate on the hour burdens the agency has previously estimated for food, drug, and medical device labeling and on the agency's knowledge of cosmetic labeling. Therefore, FDA estimates that the total hour burden on members of the public for this information collection is 140,620 hours per year. Dated: January 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-443 Filed 1-17-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection [USCBP-2006-0010] Proposed Collection; Comment Request; Guam Visa Waiver Information (I-736) AGENCY: Customs and Border Protection (CBP), Department of Homeland Security. ACTION: Notice and request for comments. SUMMARY: As part of its continuing effort to reduce paperwork and respondent burden, Customs and Border Protection
(CBP)invites the general public and other Federal agencies to comment on an information collection requirement concerning the Guam Visa Waiver Information. This proposed information collection was previously published in the **Federal Register** (70 FR 58452-58453) on October 6, 2005, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before February 17, 2006, to be assured of consideration. ADDRESSES: Direct all written comments to the Bureau of Customs and Border Protection, Attn: Tracey Denning, Information Services Group, Room 3.2.C, 1300 Pennsylvania Avenue, NW., Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to the Bureau of Customs and Border Protection, Attn.: Tracey Denning, Room 3.2.C, 1300 Pennsylvania Avenue, NW., Washington, DC 20229, Tel.
(202)344-1429. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). The comments should address:
(a)Whether the 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 estimates of the burden of the collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected;
(d)ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and
(e)estimates of capital or start-up costs and costs of operations, maintenance, and purchase of services to provide information. The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget
(OMB)approval. All comments will become a matter of public record. In this document Customs is soliciting comments concerning the following information collection: *Title:* Guam Visa Waiver Information. *OMB Number:* 1651-0109. *Form Number:* CBP Form I-736. *Abstract:* The CBP Form I-736 is used to track an alien's application for waiver of the nonimmigrant visa requirement for entry into Guam. *Current Actions:* There are no changes to the information collection. This submission is being submitted to extend the expiration date. *Type of Review:* Extension. *Affected Public:* Individuals. *Estimated Number of Respondents:* 170,000. *Estimated Time per Respondent:* 5 minutes. *Estimated Total Annual Burden Hours:* 14,110. *Estimated Total Annualized Cost on the Public:* N/A. Dated: January 10, 2006. Tracey Denning, Agency Clearance Officer, Information Services Branch. [FR Doc. 06-423 Filed 1-17-06; 8:45 am]
Connectionstraces to 6
Traces to 6 documents
6 references not yet in our index
- Pub. L. 92-463
- 44 USC 3501-3520
- 5 CFR 1320.3(c)
- 5 CFR 1320.8(d)(1)
- 21 CFR 701
- Pub. L. 104-13
Citation graph
cites case law
Notices
Notice
Pub. L.Pub. L. 92-463
Cite44 USC 3501-3520
Cite5 CFR 1320.3(c)
Cite5 CFR 1320.8(d)(1)
Cite21 CFR 701
Cites 12 · showing 11Cited by 0 across 0 sources