83 FR 13284 - Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 60 (March 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 60 (March 28, 2018)
| Page Range | 13284-13286 | |
| FR Document | 2018-06135 |
[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)] [Notices] [Pages 13284-13286] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06135] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1129] Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for a voluntary survey for the U.S. Department of [[Page 13285]] Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the U.S. Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress that is required by April 2019. The proposed survey will be used to determine what food defense activities, if any, State Agencies have completed to date. DATES: Submit either electronic or written comments on the collection of information by May 29, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 29, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-1129 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. National Agriculture and Food Defense Strategy Survey OMB Control Number--0910--New We are seeking OMB approval of the NAFDS under FSMA, section 108. This is a voluntary survey of State governments intended to gauge government activities in food and agriculture defense from intentional contamination and emerging threats. The collected information will be included in the mandatory 2019 NAFDS followup Report to Congress. The authority for FDA to collect the information derives from the [[Page 13286]] Commissioner of Food and Drugs' authority provided in section 1003(d)(2)(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(c)). Protecting the nation's food and agriculture supply against intentional contamination and other emerging threats is an important responsibility shared by Federal, State, local, tribal, and territorial governments as well as private sector partners. On January 4, 2011, the President signed FSMA. FSMA focuses on ensuring the safety of the U.S. food supply by shifting the efforts of Federal regulators from response to prevention, and recognizes the importance of strengthening existing collaboration among all stakeholders to achieve common public health and security goals. FSMA identifies some key priorities for working with partners in areas such as reliance on Federal, State, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and local food safety and defense capacities. Section 108 of FSMA (NAFDS) requires HHS and the USDA, in coordination with the DHS, to work together with State, local, territorial, and tribal governments-to monitor and measure progress in food defense. In 2015, the initial NAFDS Report to Congress detailed the specific Federal response to food and agriculture defense goals, objectives, key initiatives, and activities that HHS, USDA, DHS, and other stakeholders planned to accomplish to meet the objectives outlined in FSMA. The NAFDS charts a direction for how the Federal Agencies, in cooperation with State, local, territorial, and tribal governments and private sector partners, protect the nation's food supply against intentional contamination. Not later than 4 years after the initial NAFDS Report to Congress (2015), and every 4 years thereafter (i.e., 2019, 2023, 2017, etc.), HHS, USDA, and DHS are required to revise and submit an updated report to the relevant committees of Congress. HHS/FDA is primarily responsible for obtaining the information from Federal and State, local, territorial, and tribal partners to complete the NAFDS Report to Congress. An interagency working group will conduct the survey and collect and update the NAFDS as directed by FSMA, including developing metrics and measuring progress for the evaluation process. The proposed survey of Federal and State partners will be used to determine what food defense activities, if any, Federal and/or State Agencies have completed (or are planning) from 2015 to 2019. Planning for the local, territorial, and tribal information collections will commence after the collection and reporting of Federal and State Agency level data. This survey will be repeated approximately every 2 to 4 years, as described in section 108 of FSMA, NAFDS, for the purpose of monitoring progress in food and agricultural defense by government agencies. A purposive sampling strategy will be employed, such that the government agencies participating in food and agricultural defense cooperative agreements with FDA (22 State Agencies) and USDA (27 State Agencies) will be asked to respond to the voluntary survey. Food defense leaders responsible for conducting food defense activities during a food emergency for their jurisdiction will be identified and will receive an emailed invitation to complete the survey online; they will be provided with a web link to the survey. The survey will be conducted electronically on the FDA.gov web portal, and results will be analyzed by the interagency working group. 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- State Survey................................ 49 1 49 0.33 (20 minutes)......................... 16.17 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The total burden for this collection of information, therefore, is 16.17 hours. The FDA Office of Partnerships reviewed the questionnaire and provided the amount of time to complete the survey. The total burden is based on our previous experiences conducting surveys. Dated: March 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06135 Filed 3-27-18; 8:45 am] BILLING CODE 4164-01-P
![13284 Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
Docket; Request for Comments.’’ Federal Register about last minute notify interested persons regarding their
Received comments, those filed in a modifications that impact a previously request to speak by April 12, 2018.
timely manner (see ADDRESSES), will be announced advisory committee meeting Persons attending FDA’s advisory
placed in the docket and, except for cannot always be published quickly committee meetings are advised that
those submitted as ‘‘Confidential enough to provide timely notice. FDA is not responsible for providing
Submissions,’’ publicly viewable at Therefore, you should always check the access to electrical outlets.
https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ For press inquiries, please contact the
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and Office of Media Affairs at fdaoma@
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540.
Friday. committee meeting link, or call the FDA welcomes the attendance of the
• Confidential Submissions—To advisory committee information line to public at its advisory committee
submit a comment with confidential learn about possible modifications meetings and will make every effort to
information that you do not wish to be before coming to the meeting. accommodate persons with disabilities.
made publicly available, submit your SUPPLEMENTARY INFORMATION: If you require special accommodations
comments only as a written/paper Agenda: The committees will discuss due to a disability, please contact Jay R.
submission. You should submit two new drug application (NDA) 209904 for Fajiculay (see FOR FURTHER INFORMATION
copies total. One copy will include the stannsoporfin injection, for CONTACT) at least 7 days in advance of
information you claim to be confidential intramuscular use, submitted by the meeting.
with a heading or cover note that states InfaCare Pharmaceutical Corporation, FDA is committed to the orderly
‘‘THIS DOCUMENT CONTAINS proposed for the treatment of neonates conduct of its advisory committee
CONFIDENTIAL INFORMATION.’’ FDA greater than or equal to 35 weeks of meetings. Please visit our website at
will review this copy, including the gestational age with indicators of https://www.fda.gov/
claimed confidential information, in its hemolysis who are at risk of developing AdvisoryCommittees/
consideration of comments. The second severe hyperbilirubinemia. AboutAdvisoryCommittees/
copy, which will have the claimed FDA intends to make background ucm111462.htm for procedures on
confidential information redacted/ material available to the public no later public conduct during advisory
blacked out, will be available for public than 2 business days before the meeting. committee meetings.
viewing and posted on https:// If FDA is unable to post the background Notice of this meeting is given under
www.regulations.gov. Submit both material on its website prior to the the Federal Advisory Committee Act (5
copies to the Dockets Management Staff. meeting, the background material will U.S.C. app. 2).
If you do not wish your name and be made publicly available at the Dated: March 22, 2018.
contact information to be made publicly location of the advisory committee Leslie Kux,
available, you can provide this meeting, and the background material Associate Commissioner for Policy.
information on the cover sheet and not will be posted on FDA’s website after [FR Doc. 2018–06168 Filed 3–27–18; 8:45 am]
in the body of your comments and you the meeting. Background material is
must identify this information as BILLING CODE 4164–01–P
available at https://www.fda.gov/
‘‘confidential.’’ Any information marked AdvisoryCommittees/Calendar/
as ‘‘confidential’’ will not be disclosed default.htm. Scroll down to the DEPARTMENT OF HEALTH AND
except in accordance with 21 CFR 10.20 appropriate advisory committee meeting HUMAN SERVICES
and other applicable disclosure law. For link.
more information about FDA’s posting Procedure: Interested persons may Food and Drug Administration
of comments to public dockets, see 80 present data, information, or views,
FR 56469, September 18, 2015, or access orally or in writing, on issues pending [Docket No. FDA–2018–N–1129]
the information at: https://www.gpo.gov/ before the committees. All electronic
fdsys/pkg/FR-2015-09-18/pdf/2015- Agency Information Collection
and written submissions submitted to
23389.pdf. Activities; Proposed Collection;
the Docket (see ADDRESSES) on or before
Docket: For access to the docket to Comment Request; National
April 19, 2018, will be provided to the
read background documents or the Agriculture and Food Defense Strategy
committees. Oral presentations from the
electronic and written/paper comments Survey
public will be scheduled between
received, go to https:// approximately 1:15 p.m. and 2:15 p.m. AGENCY: Food and Drug Administration,
www.regulations.gov and insert the Those individuals interested in making HHS.
docket number, found in brackets in the formal oral presentations should notify ACTION: Notice.
heading of this document, into the the contact person and submit a brief
‘‘Search’’ box and follow the prompts statement of the general nature of the SUMMARY: The Food and Drug
and/or go to the Dockets Management evidence or arguments they wish to Administration (FDA or Agency) is
Staff, 5630 Fishers Lane, Rm. 1061, present, the names and addresses of announcing an opportunity for public
Rockville, MD 20852. proposed participants, and an comment on the proposed collection of
FOR FURTHER INFORMATION CONTACT: Jay indication of the approximate time certain information by the Agency.
R. Fajiculay, Center for Drug Evaluation requested to make their presentation on Under the Paperwork Reduction Act of
and Research, Food and Drug or before April 11, 2018. Time allotted 1995 (PRA), Federal Agencies are
Administration, 10903 New Hampshire for each presentation may be limited. If required to publish notice in the
daltland on DSKBBV9HB2PROD with NOTICES
Ave., Bldg. 31, Rm. 2417, Silver Spring, the number of registrants requesting to Federal Register concerning each
MD 20993–0002, 301–796–9001, Fax: speak is greater than can be reasonably proposed collection of information and
301–847–8533, email: GIDAC@ accommodated during the scheduled to allow 60 days for public comment in
fda.hhs.gov, or FDA Advisory open public hearing session, FDA may response to the notice. This notice
Committee Information Line, 1–800– conduct a lottery to determine the solicits comments on the information
741–8138 (301–443–0572 in the speakers for the scheduled open public collection requirements for a voluntary
Washington, DC area). A notice in the hearing session. The contact person will survey for the U.S. Department of
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![13286 Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
Commissioner of Food and Drugs’ In 2015, the initial NAFDS Report to completed (or are planning) from 2015
authority provided in section Congress detailed the specific Federal to 2019. Planning for the local,
1003(d)(2)(c) of the Federal Food, Drug, response to food and agriculture defense territorial, and tribal information
and Cosmetic Act (21 U.S.C. goals, objectives, key initiatives, and collections will commence after the
393(d)(2)(c)). activities that HHS, USDA, DHS, and collection and reporting of Federal and
Protecting the nation’s food and other stakeholders planned to State Agency level data.
agriculture supply against intentional accomplish to meet the objectives This survey will be repeated
contamination and other emerging outlined in FSMA. The NAFDS charts a approximately every 2 to 4 years, as
threats is an important responsibility direction for how the Federal Agencies, described in section 108 of FSMA,
shared by Federal, State, local, tribal, in cooperation with State, local, NAFDS, for the purpose of monitoring
and territorial governments as well as territorial, and tribal governments and progress in food and agricultural
private sector partners. On January 4, private sector partners, protect the defense by government agencies.
2011, the President signed FSMA. nation’s food supply against intentional
FSMA focuses on ensuring the safety of contamination. Not later than 4 years A purposive sampling strategy will be
the U.S. food supply by shifting the after the initial NAFDS Report to employed, such that the government
efforts of Federal regulators from Congress (2015), and every 4 years agencies participating in food and
response to prevention, and recognizes thereafter (i.e., 2019, 2023, 2017, etc.), agricultural defense cooperative
the importance of strengthening existing HHS, USDA, and DHS are required to agreements with FDA (22 State
collaboration among all stakeholders to revise and submit an updated report to Agencies) and USDA (27 State
achieve common public health and the relevant committees of Congress. Agencies) will be asked to respond to
security goals. FSMA identifies some HHS/FDA is primarily responsible for the voluntary survey. Food defense
key priorities for working with partners obtaining the information from Federal leaders responsible for conducting food
in areas such as reliance on Federal, and State, local, territorial, and tribal defense activities during a food
State, and local agencies for inspections; partners to complete the NAFDS Report emergency for their jurisdiction will be
improving foodborne illness to Congress. An interagency working identified and will receive an emailed
surveillance; and leveraging and group will conduct the survey and invitation to complete the survey
enhancing State and local food safety collect and update the NAFDS as online; they will be provided with a
and defense capacities. Section 108 of directed by FSMA, including web link to the survey. The survey will
FSMA (NAFDS) requires HHS and the developing metrics and measuring be conducted electronically on the
USDA, in coordination with the DHS, to progress for the evaluation process. FDA.gov web portal, and results will be
work together with State, local, The proposed survey of Federal and analyzed by the interagency working
territorial, and tribal governments-to State partners will be used to determine group.
monitor and measure progress in food what food defense activities, if any, FDA estimates the burden of this
defense. Federal and/or State Agencies have collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent
State Survey ............................................................ 49 1 49 0.33 (20 minutes) ...... 16.17
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The total burden for this collection of DEPARTMENT OF HEALTH AND (OMB) for review and clearance under
information, therefore, is 16.17 hours. HUMAN SERVICES the Paperwork Reduction Act of 1995.
The FDA Office of Partnerships DATES: Fax written comments on the
Food and Drug Administration
reviewed the questionnaire and collection of information by April 27,
provided the amount of time to [Docket No. FDA–2016–D–1267] 2018.
complete the survey. The total burden is
based on our previous experiences Agency Information Collection ADDRESSES: To ensure that comments on
Activities; Submission for Office of the information collection are received,
conducting surveys.
Management and Budget Review; OMB recommends that written
Dated: March 22, 2018. Comment Request; Guidance for comments be faxed to the Office of
Leslie Kux, Industry on Compounded Drug Information and Regulatory Affairs,
Associate Commissioner for Policy. Products That Are Essentially Copies OMB, Attn: FDA Desk Officer, Fax: 202–
[FR Doc. 2018–06135 Filed 3–27–18; 8:45 am]
of an Approved Drug Product Under 395–7285, or emailed to oira_
Section 503B of the Federal Food, submission@omb.eop.gov. All
BILLING CODE 4164–01–P
Drug, and Cosmetic Act comments should be identified with the
AGENCY: Food and Drug Administration, OMB control number 0910–NEW and
HHS. title ‘‘Guidance for Industry on
daltland on DSKBBV9HB2PROD with NOTICES
ACTION: Notice. Compounded Drug Products That Are
Essentially Copies of an Approved Drug
SUMMARY: The Food and Drug Product Under Section 503B of the
Administration (FDA) is announcing Federal Food, Drug, and Cosmetic Act.’’
that a proposed collection of Also include the FDA docket number
information has been submitted to the found in brackets in the heading of this
Office of Management and Budget document.
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Document Created: 2018-11-01 08:55:26
Document Modified: 2018-11-01 08:55:26
| 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 | Submit either electronic or written comments on the collection of information by May 29, 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 | 83 FR 13284 |
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