Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers, 21556-21558 [2016-08332]

Download as PDF 21556 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices Pulmonary Hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and treatment of pulmonary arterial hypertension to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. Subsequent to this approval, the USPTO received a patent term restoration application for ADEMPAS (U.S. Patent No. 7,173,037) from Bayer Intellectual Property GmbH, and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ADEMPAS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. asabaliauskas on DSK3SPTVN1PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ADEMPAS is 2,394 days. Of this time, 2,151 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: March 22, 2007. FDA has verified the Bayer Intellectual Property GmbH claim that March 22, 2007, is the date the investigational new drug application (IND) became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: February 8, 2013. FDA has verified the applicant’s claim that the new drug application (NDA) for ADEMPAS (NDA 204819) was initially submitted on February 8, 2013. 3. The date the application was approved: October 8, 2013. FDA has verified the applicant’s claim that NDA 204819 was approved on October 8, 2013. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,317 days of patent term extension. VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08337 Filed 4–11–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1904] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 May 12, 2016. SUMMARY: 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: FDA Desk Officer, FAX: ADDRESSES: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910—New and title ‘‘Comparing Food Safety Knowledge, Attitude and Behavior Among English-dominant Hispanics, Spanish-dominant Hispanics, and Other Consumers.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Comparing Food Safety Knowledge, Attitude and Behavior Among EnglishDominant Hispanics, SpanishDominant Hispanics, and Other Consumers—OMB Control Number 0910—NEW I. Background We conduct research and educational and public information programs relating to food safety and nutrition issued in our broad statutory authority, set forth in section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)), to protect the public health by ensuring that foods are ‘‘safe, wholesome, sanitary, and properly labeled,’’ and in section 1003(d)(2)(C) of the FD&C Act (21 U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, cosmetics, devices and tobacco products. Our current food safety education and outreach programs and materials generally are developed and provided for the English-speaking population in the United States (U.S.) (Ref. 1). To better protect public health and to help consumers practice safe food handling, we need empirical data on how different population groups understand, perceive and practice food safety and food handling. An emerging and important demographic trend in the United States is the increase in Hispanics. Recent estimates suggest that Hispanics (defined as those who identify themselves as of Hispanic or Latino origin) are the largest and fastest growing minority group in the nation; the proportion of the U.S. population that was Hispanic was 14 percent in 2005 and is projected to increase to 29 percent in 2050 (Ref. 2). E:\FR\FM\12APN1.SGM 12APN1 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices Data from the Centers for Disease Control and Prevention (CDC) indicate that, in the past two decades, Hispanics were one of the population groups that often experienced higher incidence rates (per 100,000 population) of bacterial causes of foodborne illness than Caucasians (Ref. 3). These bacterial causes include Campylobacter, Listeria monocytogenes (Listeria), Shigella, and Salmonella. While some Hispanics living in the United States use the English language exclusively or more often than Spanish (English-dominant Hispanics), other U.S. Hispanics predominantly use the Spanish language in their daily lives (Spanishdominant Hispanics) (Ref. 4). Since most U.S. food labels, including safe food handling instructions, are in English, Spanish-dominant Hispanics’ understanding and use of safe food handling instructions may differ from that of English-dominant Hispanics and of non-Hispanics who use English exclusively. In addition, Hispanics may have certain food handling practices that may increase their risk of foodborne illness (Ref. 5). FDA needs an understanding of how different population groups perceive and behave in terms of food safety and food handling to inform development of possible measures that we may take to better protect public health and to help consumers practice safe food handling. FDA is aware of no consumer research on a nationwide level on how different population groups understand, perceive and practice food safety and food handling. This study is intended to provide initial answers to research questions such as whether and how much Spanish-dominant Hispanics, English-dominant Hispanics, and English-speaking non-Hispanics differ in their knowledge, attitude, and behavior toward food safety and food handling and the role that demographic and other factors may play in any differences. The proposed study will use a Webbased instrument to collect information from 3,000 adult members in online consumer panels maintained by a contractor. The study plans to randomly select 1,000 panel members in each of three groups: Spanish-dominant Hispanics, English-dominant Hispanics, and English-speaking non-Hispanics. Both English and Spanish questionnaires will be used, as appropriate. The study plans to include topics such as: (1) Food safety knowledge and attitude; and (2) food handling and consumption practice. To 21557 help us understand the data, the study will also collect information on respondents’ background, including, but not limited to, health status and demographic characteristics, such as age, gender, education, and income, and degree of acculturation among Hispanic respondents using a measure developed by Marin et al. (Ref. 6). The study is part of our continuing effort to protect the public health. We will not use the results of the study to develop population estimates. We plan to use the results of the study to develop follow-up quantitative and qualitative research to gauge the prevalence and extent of differences in food safety knowledge and behaviors between the three mentioned population groups. We plan to use the results of the follow-up research to help inform the design of effective education and outreach initiatives aimed at helping reduce the risk of foodborne illness for the general U.S. population as well as Hispanics. In the Federal Register of November 28, 2014 (79 FR 70875), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Activity Total annual responses Average burden per response Total hours Cognitive interview screener ............. Cognitive interview ............................ Pretest invitation ............................... Pretest ............................................... Study invitation .................................. Study ................................................. 72 9 1,440 180 24,000 3,000 1 1 1 1 1 1 72 9 1,440 180 24,000 3,000 0.083 (5 minutes) ............................. 1.5 (90 minutes) ............................... 0.033 (2 minutes) ............................. 0.25 (15 minutes) ............................. 0.033 (2 minutes) ............................. 0.25 (15 minutes) ............................. 6 14 48 45 792 750 Total ........................................... ........................ ........................ ........................ ........................................................... 1,655 asabaliauskas on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimates on prior experience with research that is similar to this proposed study. We will use a cognitive interview screener with 72 individuals to recruit prospective interview participants. We estimate that it will take a screener respondent approximately 5 minutes (0.083 hours) to complete the cognitive interview screener, for a total of 5.976 hours, rounded to 6 hours. We will conduct cognitive interviews with nine participants. We estimate that it will take a participant approximately 90 minutes to complete the interview, for a total of 13.5 hours, rounded to 14 hours. We also plan to conduct a pretest to identify and resolve potential survey VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 administration problems. We will send a pretest invitation to 1,440 prospective pretest participants and estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the invitation, for a total of 47.52 hours, rounded to 48 hours. We will administer the pretest with 180 participants and estimate that it will take a participant 15 minutes (0.25 hours) to complete the pretest, for a total of 45 hours. We will send a study invitation to 24,000 prospective participants and estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the invitation, for a total of 792 hours. We will administer the study with 3,000 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 participants and estimate that it will take a participant 15 minutes (0.25 hours) to complete the study, for a total of 750 hours. The total estimated burden for all the study activities is 1,655 hours; this estimate is 9 hours higher than that shown in the 60-day notice due to revised hours for cognitive interviews, from 30 minutes (0.5 hours) to 90 minutes (1.5 hours) each interview. II. References 1. U.S. Food and Drug Administration. ‘‘Foodborne Illness & Contaminants.’’ June 9, 2014. (http://www.fda.gov/Food/ FoodborneIllnessContaminants/default.htm). 2. Passel, J.S. and C. D’Vera. ‘‘U.S. Population Projections: 2005–2050.’’ Pew E:\FR\FM\12APN1.SGM 12APN1 21558 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices Research Center. February 11, 2008. (http:// pewhispanic.org/files/reports/85.pdf). 3. Quinlan, J.J. ‘‘Foodborne Illness Incidence Rates and Food Safety Risks for Populations of Low Socioeconomic Status and Minority Race/Ethnicity: A Review of the Literature.’’ International Journal of Environmental Research and Public Health 10(8): 3634–3652, 2013. ´ 4. Taylor, P., M.H. Lopez, J. Martınez and G.Velasco. ‘‘Language Use Among Latinos.’’ Pew Research Center. April 4, 2012. (http:// www.pewhispanic.org/2012/04/04/ivlanguage-use-among-latinos/). 5. Henley, S.C., S.E. Stein and J.J. Quinlan. ‘‘Identification of Unique Food Handling Practices That Could Represent Food Safety Risks for Minority Consumers.’’ Journal of Food Protection 75: 2050–2054, 2012. 6. Marin, G., F. Sabogal, B.V. Marin, et al. ‘‘Development of a Short Acculturation Scale for Hispanics.’’ Hispanic Journal of Behavioral Sciences 9(2): 183–205, 1987. Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08332 Filed 4–11–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1101] EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is withdrawing approval of a new drug application (NDA) for LUVERIS (lutropin alpha for injection) held by EMD Serono, One Technology Place, Rockland, MA 02370. EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. DATES: Effective April 12, 2016. FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993–0002, 301– 796–3381. SUPPLEMENTARY INFORMATION: FDA approved LUVERIS (lutropin alpha for injection) on October 8, 2004, under the Agency’s accelerated approval regulations, 21 CFR part 314, subpart H. LUVERIS is indicated for concomitant administration with GONAL–F (follitropin alfa for injection) for stimulation of follicular development in asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 infertile hypogonadotropic hypogonadal women with profound luteinizing hormone deficiency. In a letter dated April 30, 2012, EMD Serono requested that FDA withdraw approval of NDA 021322 for LUVERIS under § 314.150(c). In that letter, EMD Serono noted that, as had been previously discussed with the Agency, it was not feasible to complete a trial that the company had agreed to at the time of approval under subpart H. By letter dated December 8, 2014, FDA notified EMD Serono that, when studies that are required as a condition of approval under the Agency’s accelerated approval regulations are not completed, the approval of an application is withdrawn according to the procedures set forth in §§ 314.530 and 314.150(d) rather than under § 314.150(c). FDA requested that EMD Serono submit a new withdrawal request under § 314.150(d). Following additional correspondence, by letter dated July 23, 2015, EMD Serono requested that FDA withdraw approval of NDA 021322 for LUVERIS under § 314.150(d) because a postmarketing study that was required as a condition of approval under subpart H was not completed. Because that study was required to verify and describe the clinical benefit of the drug product, the clinical benefit of LUVERIS has not been confirmed, and it has not been established to be safe and effective. In its July 23, 2015, letter, EMD Serono waived any opportunity for a hearing otherwise provided under §§ 314.150 and 314.530. FDA responded by letter dated September 2, 2015, acknowledging EMD Serono’s request that FDA withdraw approval of LUVERIS under § 314.150(d). FDA also acknowledged that EMD Serono waived its opportunity for a hearing. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 021322, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08336 Filed 4–11–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0560] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 May 12, 2016. ADDRESSES: 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: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0582. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. 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. SUMMARY: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable—OMB Control Number 0910–0582—Extension FDA’s investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and compliant with ethical standards. Investigators should have freedom to pursue the least burdensome means of accomplishing this goal. However, to ensure that the balance is maintained between product E:\FR\FM\12APN1.SGM 12APN1

Agencies

[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21556-21558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08332]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1904]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Comparing Food Safety 
Knowledge, Attitude and Behavior Among English-Dominant Hispanics, 
Spanish-Dominant Hispanics, and Other Consumers

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 May 12, 
2016.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--New and 
title ``Comparing Food Safety Knowledge, Attitude and Behavior Among 
English-dominant Hispanics, Spanish-dominant Hispanics, and Other 
Consumers.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

Comparing Food Safety Knowledge, Attitude and Behavior Among English-
Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers--
OMB Control Number 0910--NEW

I. Background

    We conduct research and educational and public information programs 
relating to food safety and nutrition issued in our broad statutory 
authority, set forth in section 1003(b)(2) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)), to protect the 
public health by ensuring that foods are ``safe, wholesome, sanitary, 
and properly labeled,'' and in section 1003(d)(2)(C) of the FD&C Act 
(21 U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, 
cosmetics, devices and tobacco products.
    Our current food safety education and outreach programs and 
materials generally are developed and provided for the English-speaking 
population in the United States (U.S.) (Ref. 1). To better protect 
public health and to help consumers practice safe food handling, we 
need empirical data on how different population groups understand, 
perceive and practice food safety and food handling. An emerging and 
important demographic trend in the United States is the increase in 
Hispanics. Recent estimates suggest that Hispanics (defined as those 
who identify themselves as of Hispanic or Latino origin) are the 
largest and fastest growing minority group in the nation; the 
proportion of the U.S. population that was Hispanic was 14 percent in 
2005 and is projected to increase to 29 percent in 2050 (Ref. 2).

[[Page 21557]]

    Data from the Centers for Disease Control and Prevention (CDC) 
indicate that, in the past two decades, Hispanics were one of the 
population groups that often experienced higher incidence rates (per 
100,000 population) of bacterial causes of foodborne illness than 
Caucasians (Ref. 3). These bacterial causes include Campylobacter, 
Listeria monocytogenes (Listeria), Shigella, and Salmonella. While some 
Hispanics living in the United States use the English language 
exclusively or more often than Spanish (English-dominant Hispanics), 
other U.S. Hispanics predominantly use the Spanish language in their 
daily lives (Spanish-dominant Hispanics) (Ref. 4). Since most U.S. food 
labels, including safe food handling instructions, are in English, 
Spanish-dominant Hispanics' understanding and use of safe food handling 
instructions may differ from that of English-dominant Hispanics and of 
non-Hispanics who use English exclusively. In addition, Hispanics may 
have certain food handling practices that may increase their risk of 
foodborne illness (Ref. 5).
    FDA needs an understanding of how different population groups 
perceive and behave in terms of food safety and food handling to inform 
development of possible measures that we may take to better protect 
public health and to help consumers practice safe food handling. FDA is 
aware of no consumer research on a nationwide level on how different 
population groups understand, perceive and practice food safety and 
food handling. This study is intended to provide initial answers to 
research questions such as whether and how much Spanish-dominant 
Hispanics, English-dominant Hispanics, and English-speaking non-
Hispanics differ in their knowledge, attitude, and behavior toward food 
safety and food handling and the role that demographic and other 
factors may play in any differences.
    The proposed study will use a Web-based instrument to collect 
information from 3,000 adult members in online consumer panels 
maintained by a contractor. The study plans to randomly select 1,000 
panel members in each of three groups: Spanish-dominant Hispanics, 
English-dominant Hispanics, and English-speaking non-Hispanics. Both 
English and Spanish questionnaires will be used, as appropriate. The 
study plans to include topics such as: (1) Food safety knowledge and 
attitude; and (2) food handling and consumption practice. To help us 
understand the data, the study will also collect information on 
respondents' background, including, but not limited to, health status 
and demographic characteristics, such as age, gender, education, and 
income, and degree of acculturation among Hispanic respondents using a 
measure developed by Marin et al. (Ref. 6).
    The study is part of our continuing effort to protect the public 
health. We will not use the results of the study to develop population 
estimates. We plan to use the results of the study to develop follow-up 
quantitative and qualitative research to gauge the prevalence and 
extent of differences in food safety knowledge and behaviors between 
the three mentioned population groups. We plan to use the results of 
the follow-up research to help inform the design of effective education 
and outreach initiatives aimed at helping reduce the risk of foodborne 
illness for the general U.S. population as well as Hispanics.
    In the Federal Register of November 28, 2014 (79 FR 70875), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener..              72               1              72  0.083 (5                       6
                                                                                 minutes).
Cognitive interview...........               9               1               9  1.5 (90 minutes)              14
Pretest invitation............           1,440               1           1,440  0.033 (2                      48
                                                                                 minutes).
Pretest.......................             180               1             180  0.25 (15                      45
                                                                                 minutes).
Study invitation..............          24,000               1          24,000  0.033 (2                     792
                                                                                 minutes).
Study.........................           3,000               1           3,000  0.25 (15                     750
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,655
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimates on prior experience with research that is 
similar to this proposed study. We will use a cognitive interview 
screener with 72 individuals to recruit prospective interview 
participants. We estimate that it will take a screener respondent 
approximately 5 minutes (0.083 hours) to complete the cognitive 
interview screener, for a total of 5.976 hours, rounded to 6 hours. We 
will conduct cognitive interviews with nine participants. We estimate 
that it will take a participant approximately 90 minutes to complete 
the interview, for a total of 13.5 hours, rounded to 14 hours. We also 
plan to conduct a pretest to identify and resolve potential survey 
administration problems. We will send a pretest invitation to 1,440 
prospective pretest participants and estimate that it will take a 
respondent approximately 2 minutes (0.033 hours) to complete the 
invitation, for a total of 47.52 hours, rounded to 48 hours. We will 
administer the pretest with 180 participants and estimate that it will 
take a participant 15 minutes (0.25 hours) to complete the pretest, for 
a total of 45 hours. We will send a study invitation to 24,000 
prospective participants and estimate that it will take a respondent 
approximately 2 minutes (0.033 hours) to complete the invitation, for a 
total of 792 hours. We will administer the study with 3,000 
participants and estimate that it will take a participant 15 minutes 
(0.25 hours) to complete the study, for a total of 750 hours. The total 
estimated burden for all the study activities is 1,655 hours; this 
estimate is 9 hours higher than that shown in the 60-day notice due to 
revised hours for cognitive interviews, from 30 minutes (0.5 hours) to 
90 minutes (1.5 hours) each interview.

II. References

    1. U.S. Food and Drug Administration. ``Foodborne Illness & 
Contaminants.'' June 9, 2014. (http://www.fda.gov/Food/FoodborneIllnessContaminants/default.htm).
    2. Passel, J.S. and C. D'Vera. ``U.S. Population Projections: 
2005-2050.'' Pew

[[Page 21558]]

Research Center. February 11, 2008. (http://pewhispanic.org/files/reports/85.pdf).
    3. Quinlan, J.J. ``Foodborne Illness Incidence Rates and Food 
Safety Risks for Populations of Low Socioeconomic Status and 
Minority Race/Ethnicity: A Review of the Literature.'' International 
Journal of Environmental Research and Public Health 10(8): 3634-
3652, 2013.
    4. Taylor, P., M.H. Lopez, J. Mart[iacute]nez and G.Velasco. 
``Language Use Among Latinos.'' Pew Research Center. April 4, 2012. 
(http://www.pewhispanic.org/2012/04/04/iv-language-use-among-latinos/).
    5. Henley, S.C., S.E. Stein and J.J. Quinlan. ``Identification 
of Unique Food Handling Practices That Could Represent Food Safety 
Risks for Minority Consumers.'' Journal of Food Protection 75: 2050-
2054, 2012.
    6. Marin, G., F. Sabogal, B.V. Marin, et al. ``Development of a 
Short Acculturation Scale for Hispanics.'' Hispanic Journal of 
Behavioral Sciences 9(2): 183-205, 1987.


    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08332 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P