Submission for OMB Review; 30-Day Comment Request; Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI), 26436-26437 [2014-10591]

Download as PDF 26436 Federal Register / Vol. 79, No. 89 / Thursday, May 8, 2014 / Notices docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Steven Gendel, Center for Food and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– 402–1056. SUPPLEMENTARY INFORMATION: emcdonald on DSK67QTVN1PROD with NOTICES I. Background We are announcing the availability of a draft guidance entitled, ‘‘Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.’’ This draft guidance is intended to help industry prepare petitions and notifications seeking exemptions from the labeling requirements for ingredients derived from major food allergens. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II, Pub. L. 108–282) amended the FD&C Act by defining the term ‘‘major food allergen’’ and stating that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the common or usual name of that major food allergen. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) now defines a major food allergen as ‘‘[m]ilk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans’’ and also as a food ingredient that contains protein derived from such foods. The definition excludes any highly refined oil derived from a major food allergen and any ingredient derived from such highly refined oil. In some cases, the production of an ingredient derived from a major food allergen may alter or eliminate the allergenic proteins in that derived ingredient to such an extent that it does not contain allergenic protein. In addition, a major food allergen may be used as an ingredient or as a component of an ingredient such that the level of allergenic protein in finished food products does not cause an allergic response that poses a risk to human health. Therefore, FALCPA provides two mechanisms through which such ingredients may become exempt from the labeling requirement of section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)). An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient ‘‘does not cause an allergic response that poses a risk to human health’’ (section 403(w)(6) of the VerDate Mar<15>2010 16:18 May 07, 2014 Jkt 232001 FD&C Act). Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient ‘‘does not contain allergenic protein’’ or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient ‘‘does not cause an allergic response that poses a risk to human health’’ (section 403(w)(7) of the FD&C Act). This draft guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of applicable statutes and regulations. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (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 publish notice in the Federal Register soliciting public comment on each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, we will publish a 60-day notice on the proposed collection of information in a future issue of the Federal Register. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: May 2, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–10578 Filed 5–7–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 19, 2013, Vol. 78, page 36788 and allowed 60 days for public comment. Three public comments, questions, and requests for information were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more SUMMARY: E:\FR\FM\08MYN1.SGM 08MYN1 26437 Federal Register / Vol. 79, No. 89 / Thursday, May 8, 2014 / Notices information on the proposed project, contact: Sarah Kobrin, Division of Cancer Control and Population Sciences, 9609 Medical Center Dr., MSC 9761, Rockville, MD 20852, or call nontoll-free number 240–276–6931or Email your request, including your address to: kobrins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Awareness and Beliefs about Cancer Survey, OMB No. 0925–0684, Expiration Date 11/30/2014, REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The objective of the study is gather data about American adults’ awareness and beliefs about cancer. The ultimate goal is to determine how individuals’ perceptions of cancer may influence their decisions to report signs and symptoms to health care providers, perhaps affecting the disease stage of diagnosis and the effectiveness of treatment. Data will be collected from approximately 1,500 adults aged 50 years or older across the United States will be recruited for the NCI Awareness and Beliefs about Cancer survey over a one-year period. This request is to include cellphone-only households in the ABC survey; the original request was to survey only landline households. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,667. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Type of respondent Screener ............................................ Survey ............................................... General Public .................................. Adults 50+ years old ........................ Dated: May 1, 2014. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2014–10591 Filed 5–7–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health emcdonald on DSK67QTVN1PROD with NOTICES Proposed Collection; 60-Day Comment Request; Evaluation of Center for Global Health’s (CGH) Workshops (NCI) Summary: 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 National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’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 VerDate Mar<15>2010 16:18 May 07, 2014 Jkt 232001 14,000 1,500 clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Sudha Sivaram, Program Director, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W528, Rockville MD, 20850 or call non-tollfree number 240–276–5804 or Email your request, including your address to: sudha.sivaram@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Evaluation of Center for Global Health’s (CGH) Workshops (NCI), 0925–NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This submission is a request for OMB to approve the Evaluation of Center for Global Health’s (CGH) Workshops for three years. These workshops are organized and funded by the National Cancer Institute’s CGH in conjunction with various partners PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 Average burden per response (in hours) 5/60 20/60 Total annual burden hour 1,167 500 ranging from foreign Ministries of Health and research institutions, to international non-governmental organizations (NGOs) and U.S. academic institutions. The workshops to be evaluated are the Symposiums on Global Cancer Research, Workshops in Cancer Control Planning and Implementation, the Summer Curriculum in Cancer Prevention, Women’s Empowerment Cancer Advisory Network Workshops (WE– CAN), Regional Grant Writing and Peer Review Workshops and other similar workshops. While these workshops differ in content and delivery style, their underlying goals are the same; they intend to initiate and enhance cancer control efforts, increase capacity for cancer research, foster new partnerships, and create research and cancer control networks. The proposed evaluation requests information about the outcomes of each of these workshops including (1) new cancer research partnerships and networks (2) cancer control partnerships and networks, (3) effects on cancer research, and (4) effect on cancer control planning and implementation efforts. The information will be collected 3–12 months after the workshops and is needed to evaluate the effectiveness of these workshops in order to inform future programming and funding decisions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 203. E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 79, Number 89 (Thursday, May 8, 2014)]
[Notices]
[Pages 26436-26437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10591]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Awareness and 
Beliefs About Cancer Survey, National Cancer Institute (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH), has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on June 19, 2013, Vol. 78, page 36788 and allowed 60 days for 
public comment. Three public comments, questions, and requests for 
information were received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Cancer Institute 
(NCI), National Institutes of Health may not conduct or sponsor, and 
the respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more

[[Page 26437]]

information on the proposed project, contact: Sarah Kobrin, Division of 
Cancer Control and Population Sciences, 9609 Medical Center Dr., MSC 
9761, Rockville, MD 20852, or call non-toll-free number 240-276-6931or 
Email your request, including your address to: kobrins@mail.nih.gov. 
Formal requests for additional plans and instruments must be requested 
in writing.
    Proposed Collection: Awareness and Beliefs about Cancer Survey, OMB 
No. 0925-0684, Expiration Date 11/30/2014, REVISION, National Cancer 
Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The objective of the study 
is gather data about American adults' awareness and beliefs about 
cancer. The ultimate goal is to determine how individuals' perceptions 
of cancer may influence their decisions to report signs and symptoms to 
health care providers, perhaps affecting the disease stage of diagnosis 
and the effectiveness of treatment. Data will be collected from 
approximately 1,500 adults aged 50 years or older across the United 
States will be recruited for the NCI Awareness and Beliefs about Cancer 
survey over a one-year period. This request is to include cellphone-
only households in the ABC survey; the original request was to survey 
only landline households.
    OMB approval is requested for one year. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1,667.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of        Number  of       Number of      burden per     Total annual
           Form name               respondent       respondents    responses per   response  (in    burden hour
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Screener......................  General Public..          14,000               1            5/60           1,167
Survey........................  Adults 50+ years           1,500               1           20/60             500
                                 old.
----------------------------------------------------------------------------------------------------------------


    Dated: May 1, 2014.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-10591 Filed 5-7-14; 8:45 am]
BILLING CODE 4140-01-P
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