81 FR 21556 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 70 (April 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 70 (April 12, 2016)
| Page Range | 21556-21558 | |
| FR Document | 2016-08332 |
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)] [Notices] [Pages 21556-21558] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. 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
![21556 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
Pulmonary Hypertension (CTEPH) after III. Petitions 202–395–7285, or emailed to oira_
surgical treatment or inoperable CTEPH Anyone with knowledge that any of submission@omb.eop.gov. All
to improve exercise capacity and WHO the dates as published are incorrect may comments should be identified with the
functional class; and treatment of submit either electronic or written OMB control number 0910—New and
pulmonary arterial hypertension to comments and ask for a redetermination title ‘‘Comparing Food Safety
improve exercise capacity, improve (see DATES). Furthermore, any interested Knowledge, Attitude and Behavior
WHO functional class, and to delay person may petition FDA for a Among English-dominant Hispanics,
clinical worsening. Subsequent to this determination regarding whether the Spanish-dominant Hispanics, and Other
approval, the USPTO received a patent applicant for extension acted with due Consumers.’’ Also include the FDA
term restoration application for diligence during the regulatory review docket number found in brackets in the
ADEMPAS (U.S. Patent No. 7,173,037) period. To meet its burden, the petition heading of this document.
from Bayer Intellectual Property GmbH, must be timely (see DATES) and contain FOR FURTHER INFORMATION CONTACT: FDA
and the USPTO requested FDA’s sufficient facts to merit an FDA PRA Staff, Office of Operations, Food
assistance in determining this patent’s investigation. (See H. Rept. 857, part 1, and Drug Administration, 8455
eligibility for patent term restoration. In 98th Cong., 2d sess., pp. 41–42, 1984.) Colesville Rd., COLE–14526, Silver
a letter dated March 19, 2015, FDA Petitions should be in the format Spring, MD 20993–0002, PRAStaff@
advised the USPTO that this human specified in 21 CFR 10.30. fda.hhs.gov.
drug product had undergone a Submit petitions electronically to
regulatory review period and that the SUPPLEMENTARY INFORMATION: In
http://www.regulations.gov at Docket compliance with 44 U.S.C. 3507, FDA
approval of ADEMPAS represented the No. FDA–2013–S–0610. Submit written
first permitted commercial marketing or has submitted the following proposed
petitions (two copies are required) to the collection of information to OMB for
use of the product. Thereafter, the Division of Dockets Management (HFA–
USPTO requested that FDA determine review and clearance.
305), Food and Drug Administration,
the product’s regulatory review period. 5630 Fishers Lane, Rm. 1061, Rockville, Comparing Food Safety Knowledge,
II. Determination of Regulatory Review MD 20852. Attitude and Behavior Among English-
Period Dated: April 6, 2016.
Dominant Hispanics, Spanish-
Dominant Hispanics, and Other
FDA has determined that the Leslie Kux,
Consumers—OMB Control Number
applicable regulatory review period for Associate Commissioner for Policy. 0910—NEW
ADEMPAS is 2,394 days. Of this time, [FR Doc. 2016–08337 Filed 4–11–16; 8:45 am]
I. Background
2,151 days occurred during the testing BILLING CODE 4164–01–P
phase of the regulatory review period, We conduct research and educational
while 243 days occurred during the and public information programs
approval phase. These periods of time DEPARTMENT OF HEALTH AND relating to food safety and nutrition
were derived from the following dates: HUMAN SERVICES issued in our broad statutory authority,
1. The date an exemption under set forth in section 1003(b)(2) of the
Food and Drug Administration Federal Food, Drug, and Cosmetic Act
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 [Docket No. FDA–2014–N–1904] (the FD&C Act) (21 U.S.C. 393(b)(2)), to
U.S.C. 355(i)) became effective: March protect the public health by ensuring
22, 2007. FDA has verified the Bayer Agency Information Collection that foods are ‘‘safe, wholesome,
Intellectual Property GmbH claim that Activities; Submission for Office of sanitary, and properly labeled,’’ and in
March 22, 2007, is the date the Management and Budget Review; section 1003(d)(2)(C) of the FD&C Act
investigational new drug application Comment Request; Comparing Food (21 U.S.C. 393(d)(2)(C)), to conduct
(IND) became effective. Safety Knowledge, Attitude and research relating to foods, drugs,
Behavior Among English-Dominant cosmetics, devices and tobacco
2. The date the application was Hispanics, Spanish-Dominant products.
initially submitted with respect to the Hispanics, and Other Consumers Our current food safety education and
human drug product under section
outreach programs and materials
505(b) of the FD&C Act: February 8, AGENCY: Food and Drug Administration,
generally are developed and provided
2013. FDA has verified the applicant’s HHS.
for the English-speaking population in
claim that the new drug application ACTION: Notice. the United States (U.S.) (Ref. 1). To
(NDA) for ADEMPAS (NDA 204819)
SUMMARY: The Food and Drug better protect public health and to help
was initially submitted on February 8,
Administration (FDA) is announcing consumers practice safe food handling,
2013.
that a proposed collection of we need empirical data on how different
3. The date the application was population groups understand, perceive
approved: October 8, 2013. FDA has information has been submitted to the
Office of Management and Budget and practice food safety and food
verified the applicant’s claim that NDA handling. An emerging and important
204819 was approved on October 8, (OMB) for review and clearance under
the Paperwork Reduction Act of 1995. demographic trend in the United States
2013. is the increase in Hispanics. Recent
DATES: Fax written comments on the
This determination of the regulatory estimates suggest that Hispanics
asabaliauskas on DSK3SPTVN1PROD with NOTICES
review period establishes the maximum collection of information by May 12, (defined as those who identify
potential length of a patent extension. 2016. themselves as of Hispanic or Latino
However, the USPTO applies several ADDRESSES: To ensure that comments on origin) are the largest and fastest
statutory limitations in its calculations the information collection are received, growing minority group in the nation;
of the actual period for patent extension. OMB recommends that written the proportion of the U.S. population
In its application for patent extension, comments be faxed to the Office of that was Hispanic was 14 percent in
this applicant seeks 1,317 days of patent Information and Regulatory Affairs, 2005 and is projected to increase to 29
term extension. OMB, Attn: FDA Desk Officer, FAX: percent in 2050 (Ref. 2).
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![21558 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
Research Center. February 11, 2008. (http:// infertile hypogonadotropic hypogonadal DEPARTMENT OF HEALTH AND
pewhispanic.org/files/reports/85.pdf). women with profound luteinizing HUMAN SERVICES
3. Quinlan, J.J. ‘‘Foodborne Illness hormone deficiency. In a letter dated
Incidence Rates and Food Safety Risks for Food and Drug Administration
Populations of Low Socioeconomic Status
April 30, 2012, EMD Serono requested
and Minority Race/Ethnicity: A Review of the that FDA withdraw approval of NDA [Docket No. FDA–2012–N–0560]
Literature.’’ International Journal of 021322 for LUVERIS under § 314.150(c).
Environmental Research and Public Health In that letter, EMD Serono noted that, as Agency Information Collection
10(8): 3634–3652, 2013. had been previously discussed with the Activities; Submission for Office of
4. Taylor, P., M.H. Lopez, J. Martı́nez and Agency, it was not feasible to complete Management and Budget Review;
G.Velasco. ‘‘Language Use Among Latinos.’’ a trial that the company had agreed to Comment Request; Guidance on
Pew Research Center. April 4, 2012. (http:// Informed Consent for In Vitro
at the time of approval under subpart H.
www.pewhispanic.org/2012/04/04/iv-
language-use-among-latinos/). By letter dated December 8, 2014, FDA Diagnostic Device Studies Using
5. Henley, S.C., S.E. Stein and J.J. Quinlan. notified EMD Serono that, when studies Leftover Human Specimens
‘‘Identification of Unique Food Handling that are required as a condition of AGENCY: Food and Drug Administration,
Practices That Could Represent Food Safety approval under the Agency’s accelerated HHS.
Risks for Minority Consumers.’’ Journal of approval regulations are not completed,
Food Protection 75: 2050–2054, 2012. ACTION: Notice.
the approval of an application is
6. Marin, G., F. Sabogal, B.V. Marin, et al. withdrawn according to the procedures SUMMARY: The Food and Drug
‘‘Development of a Short Acculturation Scale
set forth in §§ 314.530 and 314.150(d) Administration (FDA) is announcing
for Hispanics.’’ Hispanic Journal of
Behavioral Sciences 9(2): 183–205, 1987. rather than under § 314.150(c). FDA that a proposed collection of
requested that EMD Serono submit a information has been submitted to the
Dated: April 6, 2016. new withdrawal request under Office of Management and Budget
Leslie Kux, § 314.150(d). (OMB) for review and clearance under
Associate Commissioner for Policy. Following additional correspondence, the Paperwork Reduction Act of 1995.
[FR Doc. 2016–08332 Filed 4–11–16; 8:45 am] by letter dated July 23, 2015, EMD DATES: Fax written comments on the
BILLING CODE 4164–01–P Serono requested that FDA withdraw collection of information by May 12,
approval of NDA 021322 for LUVERIS 2016.
under § 314.150(d) because a ADDRESSES: To ensure that comments on
DEPARTMENT OF HEALTH AND postmarketing study that was required the information collection are received,
HUMAN SERVICES as a condition of approval under subpart OMB recommends that written
H was not completed. Because that comments be faxed to the Office of
Food and Drug Administration study was required to verify and Information and Regulatory Affairs,
[Docket No. FDA–2016–N–1101] describe the clinical benefit of the drug OMB, Attn: FDA Desk Officer, FAX:
product, the clinical benefit of LUVERIS 202–395–7285, or emailed to oira_
EMD Serono; Withdrawal of Approval has not been confirmed, and it has not submission@omb.eop.gov. All
of a New Drug Application for LUVERIS been established to be safe and effective. comments should be identified with the
AGENCY: Food and Drug Administration, In its July 23, 2015, letter, EMD Serono OMB control number 0910–0582. Also
HHS. waived any opportunity for a hearing include the FDA docket number found
otherwise provided under §§ 314.150 in brackets in the heading of this
ACTION: Notice.
and 314.530. FDA responded by letter document.
SUMMARY: The Food and Drug dated September 2, 2015, FOR FURTHER INFORMATION CONTACT: FDA
Administration (FDA or the Agency) is acknowledging EMD Serono’s request PRA Staff, Office of Operations, Food
withdrawing approval of a new drug that FDA withdraw approval of and Drug Administration, 8455
application (NDA) for LUVERIS LUVERIS under § 314.150(d). FDA also Colesville Rd., COLE–14526, Silver
(lutropin alpha for injection) held by acknowledged that EMD Serono waived Spring, MD 20993–0002, PRAStaff@
EMD Serono, One Technology Place, its opportunity for a hearing. fda.hhs.gov.
Rockland, MA 02370. EMD Serono has Therefore, under section 505(e) of the SUPPLEMENTARY INFORMATION: In
voluntarily requested that approval of Federal Food, Drug, and Cosmetic Act
this application be withdrawn, thereby compliance with 44 U.S.C. 3507, FDA
(FD&C Act) (21 U.S.C. 355(e)) and has submitted the following proposed
waiving its opportunity for a hearing. § 314.150(d), and under authority collection of information to OMB for
DATES: Effective April 12, 2016. delegated by the Commissioner to the review and clearance.
FOR FURTHER INFORMATION CONTACT: Director, Center for Drug Evaluation and
Emily Helms Williams, Center for Drug Research, approval of NDA 021322, and Guidance on Informed Consent for In
Evaluation and Research, Food and all amendments and supplements Vitro Diagnostic Device Studies Using
Drug Administration, 10903 New thereto, is withdrawn (see DATES). Leftover Human Specimens That Are
Hampshire Ave., Bldg. 51, Rm. 6280, Distribution of this product in interstate Not Individually Identifiable—OMB
Silver Spring, MD 20993–0002, 301– commerce without an approved Control Number 0910–0582—Extension
796–3381. application is illegal and subject to FDA’s investigational device
SUPPLEMENTARY INFORMATION: FDA regulatory action (see sections 505(a) regulations are intended to encourage
asabaliauskas on DSK3SPTVN1PROD with NOTICES
approved LUVERIS (lutropin alpha for and 301(d) of the FD&C Act (21 U.S.C. the development of new, useful devices
injection) on October 8, 2004, under the 355(a) and 331(d)). in a manner that is consistent with
Agency’s accelerated approval Dated: April 6, 2016. public health, safety, and compliant
regulations, 21 CFR part 314, subpart H. with ethical standards. Investigators
Leslie Kux,
LUVERIS is indicated for concomitant should have freedom to pursue the least
administration with GONAL–F Associate Commissioner for Policy. burdensome means of accomplishing
(follitropin alfa for injection) for [FR Doc. 2016–08336 Filed 4–11–16; 8:45 am] this goal. However, to ensure that the
stimulation of follicular development in BILLING CODE 4164–01–P balance is maintained between product
VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1](https://thefederalregister.org/doc/81_FR_21626/page/3.svg)
Document Created: 2016-04-12 00:46:49
Document Modified: 2016-04-12 00:46:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 12, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 21556 |
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