82 FR 57760 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 234 (December 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 234 (December 7, 2017)
| Page Range | 57760-57761 | |
| FR Document | 2017-26356 |
[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)] [Notices] [Pages 57760-57761] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26356] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1161] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 January 8, 2018. 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 0910-0345. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. Food Safety Survey OMB Control Number 0910-0345--Extension Under section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)), we are authorized [[Page 57761]] to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nation's food supply. The Food Safety Survey measures consumers' knowledge, attitudes, and beliefs about food safety. Previous versions of the survey were collected in 1988, 1993, 1998, 2001, 2006, 2010, and 2016. Food Safety Survey data are used to measure trends in consumer food safety habits including hand and cutting board washing, cooking practices, and use of food thermometers. Data are also used to evaluate educational messages and to inform policymakers about consumer attitudes about technologies such as food irradiation and biotechnology. The proposed Food Safety Survey will contain many of the same questions and topics as previous Food Safety Surveys to facilitate measuring trends in food safety knowledge, attitudes, and behaviors over time. The proposed survey will also be updated to explore emerging consumer food safety topics and expand understanding of previously asked topics. The methods for the proposed Food Safety Survey will be largely the same as those used with the previous Food Safety Surveys with the exception of the inclusion of address based sampling (ABS) methods to explore the method as a possible alternative for new survey questions. ABS is sampling from address frames that are usually based, in part, on residential addresses in the U.S. Postal Service Computerized Delivery Sequence File. ABS is a cost effective method of sampling that provides much coverage of U.S. households for in-person, mail, telephone, and multimode surveys (including web-based surveys.) The Food Safety Survey will continue to include cell phones in addition to landlines for the telephone interviews. A nationally representative sample of 4,000 adults will be selected at random to complete the survey. The survey will also include an oversample of Hispanics and Blacks to ensure a minimum of 400 each. Additionally, methods will be employed to test for the presence of response bias. Participation in the survey will be voluntary. Cognitive interviews and a pre-test will be conducted prior to fielding the survey. In the Federal Register of July 3, 2017 (82 FR 30871), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received two comments. One commenter discussed the importance of food safety, for which FDA agrees, and one commenter provided a comment which was unrelated to the information collection. After evaluating these comments, FDA will not revise the information collection. 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 per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Cognitive interview screener.............. 75 1 75 0.083 (5 minutes)........................... 6 Cognitive interview....................... 9 1 9 1........................................... 9 Pretest screener.......................... 45 1 45 0.0167 (1 minute)........................... 1 Pretest................................... 18 1 18 0.33 (20 minutes)........................... 6 Survey screener........................... 10,000 1 10,000 0.0167 (1 minute)........................... 167 Survey.................................... 4,000 1 4,000 0.33 (20 minutes)........................... 1,320 Non-response survey screener.............. 125 1 125 0.0167 (1 minute)........................... 2 Non-response survey....................... 50 1 50 0.167 (10 minutes).......................... 8 ------------------------------------------------------------------------------------------------------------- Total................................. .............. .............. .............. ............................................ 1,519 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's burden estimate is based on the Agency's prior experience with the Food Safety Survey. FDA estimates that the burden hours for this information collection will remain the same since the last OMB approval. Dated: December 1, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26356 Filed 12-6-17; 8:45 am] BILLING CODE 4164-01-P
![57760 Federal Register / Vol. 82, No. 234 / Thursday, December 7, 2017 / Notices
redacted/blacked out, will be available among other things, a multi-arm, multi- Guidances/default.htm or https://
for public viewing and posted on company clinical trial as a novel www.regulations.gov.
https://www.regulations.gov. Submit approach to enhance the efficiency of Dated: December 1, 2017.
both copies to the Dockets Management drug development in pediatric rare Leslie Kux,
Staff. If you do not wish your name and diseases using pediatric Gaucher disease
Associate Commissioner for Policy.
contact information to be made publicly as an example. The proposal applies
only to systemic (i.e., non-neurological) [FR Doc. 2017–26357 Filed 12–6–17; 8:45 am]
available, you can provide this
information on the cover sheet and not manifestations of Gaucher disease (i.e., BILLING CODE 4164–01–P
in the body of your comments and you patients with Type I and Type III
must identify this information as phenotypes).
The purpose of this guidance is to DEPARTMENT OF HEALTH AND
‘‘confidential.’’ Any information marked
facilitate drug development in pediatric HUMAN SERVICES
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20 rare diseases, with a focus on Gaucher
Food and Drug Administration
and other applicable disclosure law. For disease. In this guidance, Gaucher
more information about FDA’s posting disease is provided as a disease model. [Docket No. FDA–2013–N–1161]
of comments to public dockets, see 80 However, the principles underlying this
FR 56469, September 18, 2015, or access proposal may be extended to other areas Agency Information Collection
the information at: https://www.gpo.gov/ of drug development in rare diseases. Activities; Submission for Office of
fdsys/pkg/FR-2015-09-18/pdf/2015- The guidance was originally a document Management and Budget Review;
23389.pdf. developed as a strategic collaboration Comment Request; Food Safety
Docket: For access to the docket to between FDA and the European Survey
read background documents or the Medicines Agency to enhance the AGENCY: Food and Drug Administration,
electronic and written/paper comments efficiency of drug development in HHS.
received, go to https:// Gaucher disease, which was released in
ACTION: Notice.
www.regulations.gov and insert the 2014 for public comment. The draft
docket number, found in brackets in the guidance is an updated version of the SUMMARY: The Food and Drug
heading of this document, into the document and has no fundamental Administration (FDA, Agency, or we) is
‘‘Search’’ box and follow the prompts changes to the original intent and announcing that a proposed collection
and/or go to the Dockets Management content. of information has been submitted to the
Staff, 5630 Fishers Lane, Rm. 1061, This draft guidance is being issued Office of Management and Budget
Rockville, MD 20852. consistent with FDA’s good guidance (OMB) for review and clearance under
You may submit comments on any practices regulation (21 CFR 10.115). the Paperwork Reduction Act of 1995.
guidance at any time (see 21 CFR The draft guidance, when finalized, will DATES: Fax written comments on the
10.115(g)(5)). represent the current thinking of FDA collection of information by January 8,
Submit written requests for single on ‘‘Pediatric Rare Diseases—A 2018.
copies of the draft guidance to the Collaborative Approach for Drug
ADDRESSES: To ensure that comments on
Division of Drug Information, Center for Development Using Gaucher Disease as
a Model.’’ It does not establish any the information collection are received,
Drug Evaluation and Research, Food OMB recommends that written
and Drug Administration, 10001 New rights for any person and is not binding
on FDA or the public. You can use an comments be faxed to the Office of
Hampshire Ave., Hillandale Building, Information and Regulatory Affairs,
4th Floor, Silver Spring, MD 20993– alternative approach if it satisfies the
requirements of the applicable statutes OMB, Attn: FDA Desk Officer, Fax: 202–
0002. Send one self-addressed adhesive 395–7285, or emailed to oira_
label to assist that office in processing and regulations. This guidance is not
subject to Executive Order 12866. submission@omb.eop.gov. All
your requests. See the SUPPLEMENTARY comments should be identified with the
INFORMATION section for electronic II. The Paperwork Reduction Act of OMB control number 0910–0345. Also
access to the draft guidance document. 1995 include the FDA docket number found
FOR FURTHER INFORMATION CONTACT: This draft guidance refers to in brackets in the heading of this
Hong Vu, Center for Drug Evaluation previously approved collections of document.
and Research, Food and Drug information found in FDA regulations. FOR FURTHER INFORMATION CONTACT: Ila
Administration, 10903 New Hampshire These collections of information are S. Mizrachi, Office of Operations, Food
Ave., Bldg. 22, Rm. 5345, Silver Spring, subject to review by the Office of and Drug Administration, Three White
MD 20993–0002, 301–796–7401. Management and Budget (OMB) under Flint North, 10A–12M, 11601
SUPPLEMENTARY INFORMATION: the Paperwork Reduction Act of 1995 Landsdown St., North Bethesda, MD
I. Background (44 U.S.C. 3501–3520). The collections 20852, 301–796–7726, PRAStaff@
of information in 21 CFR parts 312 and fda.hhs.gov.
FDA is announcing the availability of 314 have been approved under OMB
a draft guidance for industry entitled SUPPLEMENTARY INFORMATION: In
control numbers 0910–0014 and 0910–
‘‘Pediatric Rare Diseases—A compliance with 44 U.S.C. 3507, FDA
0001, respectively. The collections of
Collaborative Approach for Drug has submitted the following proposed
information in 21 CFR 201.57 for the
Development Using Gaucher Disease as collection of information to OMB for
content and format of prescription drug
a Model.’’ The emergence of review and clearance.
sradovich on DSK3GMQ082PROD with NOTICES
labeling was approved under OMB
concomitant trials for multiple control number 0910–0572. Food Safety Survey
investigational drug products for the
treatment of rare disease can pose III. Electronic Access OMB Control Number 0910–0345—
significant challenges to effective drug Persons with access to the internet Extension
development, given the limited number may obtain the draft guidance at either Under section 1003(b)(2) of the
of patients worldwide with these https://www.fda.gov/Drugs/Guidance Federal Food, Drug, and Cosmetic Act
diagnoses. This guidance discusses, ComplianceRegulatoryInformation/ (21 U.S.C. 393(b)(2)), we are authorized
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![Federal Register / Vol. 82, No. 234 / Thursday, December 7, 2017 / Notices 57761
to conduct research relating to foods survey will also be updated to explore to complete the survey. The survey will
and to conduct educational and public emerging consumer food safety topics also include an oversample of Hispanics
information programs relating to the and expand understanding of previously and Blacks to ensure a minimum of 400
safety of the nation’s food supply. The asked topics. each. Additionally, methods will be
Food Safety Survey measures The methods for the proposed Food employed to test for the presence of
consumers’ knowledge, attitudes, and Safety Survey will be largely the same response bias. Participation in the
beliefs about food safety. Previous as those used with the previous Food survey will be voluntary. Cognitive
versions of the survey were collected in Safety Surveys with the exception of the interviews and a pre-test will be
1988, 1993, 1998, 2001, 2006, 2010, and inclusion of address based sampling
conducted prior to fielding the survey.
2016. Food Safety Survey data are used (ABS) methods to explore the method as
to measure trends in consumer food a possible alternative for new survey In the Federal Register of July 3, 2017
safety habits including hand and cutting questions. ABS is sampling from (82 FR 30871), FDA published a 60-day
board washing, cooking practices, and address frames that are usually based, in notice requesting public comment on
use of food thermometers. Data are also part, on residential addresses in the U.S. the proposed collection of information.
used to evaluate educational messages Postal Service Computerized Delivery We received two comments. One
and to inform policymakers about Sequence File. ABS is a cost effective commenter discussed the importance of
consumer attitudes about technologies method of sampling that provides much food safety, for which FDA agrees, and
such as food irradiation and coverage of U.S. households for in- one commenter provided a comment
biotechnology. person, mail, telephone, and multimode which was unrelated to the information
The proposed Food Safety Survey will surveys (including web-based surveys.) collection. After evaluating these
contain many of the same questions and The Food Safety Survey will continue to comments, FDA will not revise the
topics as previous Food Safety Surveys include cell phones in addition to information collection.
to facilitate measuring trends in food landlines for the telephone interviews.
safety knowledge, attitudes, and A nationally representative sample of FDA estimates the burden of this
behaviors over time. The proposed 4,000 adults will be selected at random collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total
Number of Average burden
Activity responses per annual Total hours
respondents per response
respondent responses
Cognitive interview screener ............................... 75 1 75 0.083 (5 minutes) ........... 6
Cognitive interview .............................................. 9 1 9 1 ..................................... 9
Pretest screener .................................................. 45 1 45 0.0167 (1 minute) .......... 1
Pretest ................................................................. 18 1 18 0.33 (20 minutes) ........... 6
Survey screener .................................................. 10,000 1 10,000 0.0167 (1 minute) .......... 167
Survey ................................................................. 4,000 1 4,000 0.33 (20 minutes) ........... 1,320
Non-response survey screener ........................... 125 1 125 0.0167 (1 minute) .......... 2
Non-response survey .......................................... 50 1 50 0.167 (10 minutes) ......... 8
Total ............................................................. ........................ ........................ ........................ ........................................ 1,519
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on the amended, notice is hereby given of the Place: National Institutes of Health, 5601
Agency’s prior experience with the following meeting. Fishers Lane, Rockville, MD 20892
Food Safety Survey. FDA estimates that (Telephone Conference Call).
The meeting will be closed to the
the burden hours for this information Contact Person: Jay R. Radke, Ph.D.,
public in accordance with the Scientific Review Officer, Scientific Review
collection will remain the same since provisions set forth in sections Program, Division of Extramural Activities,
the last OMB approval. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Room #3G11B, National Institutes of Health,
Dated: December 1, 2017. as amended. The grant applications and NIAID, 5601 Fishers Lane MSC–9823,
Leslie Kux, the discussions could disclose Bethesda, MD 20892–9823, (240) 669–5046,
Associate Commissioner for Policy. confidential trade secrets or commercial jay.radke@nih.gov.
[FR Doc. 2017–26356 Filed 12–6–17; 8:45 am]
property such as patentable material, (Catalogue of Federal Domestic Assistance
and personal information concerning Program Nos. 93.855, Allergy, Immunology,
BILLING CODE 4164–01–P
individuals associated with the grant and Transplantation Research; 93.856,
applications, the disclosure of which Microbiology and Infectious Diseases
DEPARTMENT OF HEALTH AND would constitute a clearly unwarranted Research, National Institutes of Health, HHS)
HUMAN SERVICES invasion of personal privacy. Dated: December 1, 2017.
Name of Committee: National Institute of Natasha M. Copeland,
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
Allergy and Infectious Diseases Special Program Analyst, Office of Federal Advisory
Emphasis Panel; NIAID Clinical Trial Committee Policy.
National Institute of Allergy and Implementation Cooperative Agreement
[FR Doc. 2017–26324 Filed 12–6–17; 8:45 am]
Infectious Diseases; Notice of Closed (U01).
Meeting BILLING CODE 4140–01–P
Date: January 9, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Pursuant to section 10(d) of the Agenda: To review and evaluate grant
Federal Advisory Committee Act, as applications.
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Document Created: 2017-12-07 00:34:38
Document Modified: 2017-12-07 00:34:38
| 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 January 8, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 57760 |
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