81_FR_42839 81 FR 42713 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Extension of Comment Period

81 FR 42713 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 126 (June 30, 2016)

Page Range42713-42714
FR Document2016-15475

The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of May 5, 2016. In the notice, FDA announced an opportunity for public comment on the proposed collection of certain information by the Agency. We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.

Federal Register, Volume 81 Issue 126 (Thursday, June 30, 2016) 
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42713-42714]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0065]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Registration of Food Facilities Under the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice that appeared in the Federal Register of 
May 5, 2016. In the notice, FDA announced an opportunity for public 
comment on the proposed collection of certain information by the 
Agency. We are taking this action due to maintenance on the Federal 
eRulemaking portal from July 1 through July 5, 2016.

DATES: FDA is extending the comment period on the notice published May 
5, 2016 (81 FR 27140). Submit either electronic or written comments by 
July 12, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2013-N-0065 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Registration of Food Facilities 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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

[[Page 42714]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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 the Federal Register of May 5, 2016 (81 
FR 27140), FDA published a notice giving interested persons until July 
5, 2016, to comment on the information collection provisions of the 
Agency's regulations that require registration for domestic and foreign 
facilities that manufacture, process, pack, or hold food for human or 
animal consumption in the United States.
    From July 1 through July 5, 2016, the Federal eRulemaking Portal, 
http://www.regulations.gov, is undergoing maintenance. We are, 
therefore, extending the comment period for commenting on the 
information collection provisions of the Agency's regulations that 
require registration for domestic and foreign facilities that 
manufacture, process, pack, or hold food for human or animal 
consumption in the United States. The extended comment period will 
close on July 12, 2016.

    Dated: June 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15475 Filed 6-29-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices 42713 in 44 U.S.C. 3502(3) and 5 CFR Dated: June 23, 2016. comments, that information will be 1320.3(c) and includes agency request Kathy Greenlee, posted on http://www.regulations.gov. or requirements that members of the Administrator and Assistant Secretary for • If you want to submit a comment public submit reports, keep records, or Aging. with confidential information that you provide information to a third party. [FR Doc. 2016–15433 Filed 6–29–16; 8:45 am] do not wish to be made available to the Section 3506(c)(2)(A) of the PRA (44 BILLING CODE 4154–01–P public, submit the comment as a U.S.C. 3506(c)(2)(A)) requires Federal written/paper submission and in the agencies to provide a 60-day notice in manner detailed (see ‘‘Written/Paper DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). the Federal Register concerning each proposed collection of information, HUMAN SERVICES Written/Paper Submissions including each proposed extension of an Food and Drug Administration Submit written/paper submissions as existing collection of information, follows: before submitting the collection to OMB [Docket No. FDA–2013–N–0065] • Mail/Hand delivery/Courier (for for approval. To comply with this Agency Information Collection written/paper submissions): Division of requirement, ACL/AoA is publishing Activities; Proposed Collection; Dockets Management (HFA–305), Food notice of the proposed collection of Comment Request; Registration of and Drug Administration, 5630 Fishers information set forth in this document. Food Facilities Under the Public Health Lane, Rm. 1061, Rockville, MD 20852. With respect to the following collection • For written/paper comments Security and Bioterrorism of information, AoA invites comments submitted to the Division of Dockets Preparedness and Response Act of on: (1) Whether the proposed collection Management, FDA will post your 2002; Extension of Comment Period of information is necessary for the comment, as well as any attachments, AGENCY: Food and Drug Administration, except for information submitted, proper performance of AoA’s functions, HHS. marked and identified, as confidential, including whether the information will ACTION: Notice; extension of comment if submitted as detailed in have practical utility; (2) the accuracy of ‘‘Instructions.’’ AoA’s estimate of the burden of the period. Instructions: All submissions received proposed collection of information, SUMMARY: The Food and Drug must include the Docket No. FDA– including the validity of the Administration (FDA or we) is 2013–N–0065 for ‘‘Agency Information methodology and assumptions used; (3) extending the comment period for the Collection Activities; Proposed ways to enhance the quality, utility, and notice that appeared in the Federal Collection; Comment Request; clarity of the information to be Register of May 5, 2016. In the notice, Registration of Food Facilities Under the collected; and (4) ways to minimize the FDA announced an opportunity for Public Health Security and Bioterrorism burden of the collection of information public comment on the proposed Preparedness and Response Act of on respondents, including through the collection of certain information by the 2002.’’ Received comments will be use of automated collection techniques Agency. We are taking this action due placed in the docket and, except for when appropriate, and other forms of to maintenance on the Federal those submitted as ‘‘Confidential information technology. eRulemaking portal from July 1 through Submissions,’’ publicly viewable at July 5, 2016. http://www.regulations.gov or at the Section 1327.21 (conflicts of interest) DATES: FDA is extending the comment Division of Dockets Management of the Long-Term Care Ombudsman period on the notice published May 5, between 9 a.m. and 4 p.m., Monday Program rule requires the State agency 2016 (81 FR 27140). Submit either through Friday. and the Ombudsman to identify and • Confidential Submissions—To electronic or written comments by July take steps to remove or remedy submit a comment with confidential 12, 2016. organizational conflicts of interest information that you do not wish to be ADDRESSES: You may submit comments between the Office and the State agency made publicly available, submit your as follows: or other agency carrying out the comments only as a written/paper Ombudsman program. Additionally the Electronic Submissions submission. You should submit two rule requires the Ombudsman to Submit electronic comments in the copies total. One copy will include the identify organizational conflicts of following way: information you claim to be confidential interest in the Ombudsman program and • Federal eRulemaking Portal: http:// with a heading or cover note that states describe steps taken to remove or www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS remedy conflicts within the annual instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The report submitted to the Assistant Comments submitted electronically, Agency will review this copy, including Secretary through the National including attachments, to http:// the claimed confidential information, in Ombudsman Reporting System. The www.regulations.gov will be posted to its consideration of comments. The proposed form and instructions are the docket unchanged. Because your second copy, which will have the posted on the ACL/AoA Web site at: comment will be made public, you are claimed confidential information http://www.aoa.acl.gov/AoA_Programs/ solely responsible for ensuring that your redacted/blacked out, will be available Elder_Rights/Ombudsman/index.aspx. comment does not include any for public viewing and posted on http:// confidential information that you or a www.regulations.gov. Submit both AoA estimates the burden of this third party may not wish to be posted, copies to the Division of Dockets mstockstill on DSK3G9T082PROD with NOTICES additional collection of information as such as medical information, your or Management. If you do not wish your follows: Approximately 10 to 30 anyone else’s Social Security number, or name and contact information to be minutes per respondent, depending on confidential business information, such made publicly available, you can the number of conflicts to report, with as a manufacturing process. Please note provide this information on the cover 52 state Ombudsman programs that if you include your name, contact sheet and not in the body of your responding annually for a range of 8.6 information, or other information that comments and you must identify this to 26 hours. identifies you in the body of your information as ‘‘confidential.’’ Any VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

42714 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices information marked as ‘‘confidential’’ DEPARTMENT OF HEALTH AND do not wish to be made available to the will not be disclosed except in HUMAN SERVICES public, submit the comment as a accordance with 21 CFR 10.20 and other written/paper submission and in the applicable disclosure law. For more Food and Drug Administration manner detailed (see ‘‘Written/Paper information about FDA’s posting of [Docket No. FDA–2016–D–1099] Submissions’’ and ‘‘Instructions’’). comments to public dockets, see 80 FR Written/Paper Submissions 56469, September 18, 2015, or access Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance Submit written/paper submissions as the information at: http://www.fda.gov/ for Industry; Supporting Document for follows: regulatoryinformation/dockets/ • Mail/Hand delivery/Courier (for default.htm. Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in written/paper submissions): Division of Docket: For access to the docket to Rice and Rice Products Risk Dockets Management (HFA–305), Food read background documents or the Assessment: Report; Availability; and Drug Administration, 5630 Fishers electronic and written/paper comments Extension of the Comment Period Lane, Rm. 1061, Rockville, MD 20852. received, go to http:// • For written/paper comments www.regulations.gov and insert the AGENCY: Food and Drug Administration, submitted to the Division of Dockets docket number, found in brackets in the HHS. Management, FDA will post your heading of this document, into the ACTION: Notice of availability; extension comment, as well as any attachments, of the comment period. except for information submitted, ‘‘Search’’ box and follow the prompts marked and identified, as confidential, and/or go to the Division of Dockets SUMMARY: The Food and Drug if submitted as detailed in Management, 5630 Fishers Lane, Rm. Administration (FDA or we) is ‘‘Instructions.’’ 1061, Rockville, MD 20852. extending the comment period for the Instructions: All submissions received FOR FURTHER INFORMATION CONTACT: FDA notice, published in the Federal must include the Docket No. FDA– PRA Staff, Office of Operations, Food Register of April 6, 2016 (81 FR 19976), 2016–D–1099 for ‘‘Inorganic Arsenic in and Drug Administration, 8455 announcing the availability of a draft Rice Cereals for Infants: Action Level; Colesville Rd., COLE–14526, Silver guidance for industry entitled Draft Guidance for Industry; Supporting Spring, MD 20993–0002, PRAStaff@ ‘‘Inorganic Arsenic in Rice Cereals for Document for Action Level for Inorganic Infants: Action Level,’’ a supporting Arsenic in Rice Cereals for Infants; fda.hhs.gov. document entitled ‘‘Supporting Arsenic in Rice and Rice Products Risk SUPPLEMENTARY INFORMATION: In the Document for Action Level for Inorganic Assessment: Report; Availability.’’ Federal Register of May 5, 2016 (81 FR Arsenic in Rice Cereals for Infants,’’ and Received comments will be placed in 27140), FDA published a notice giving a risk assessment report entitled the docket and, except for those interested persons until July 5, 2016, to ‘‘Arsenic in Rice and Rice Products Risk submitted as ‘‘Confidential comment on the information collection Assessment: Report.’’ We are taking this Submissions,’’ publicly viewable at provisions of the Agency’s regulations action due to maintenance on the http://www.regulations.gov or at the Federal eRulemaking portal in early July Division of Dockets Management that require registration for domestic 2016. between 9 a.m. and 4 p.m., Monday and foreign facilities that manufacture, DATES: Submit either electronic or through Friday. process, pack, or hold food for human • Confidential Submissions—To or animal consumption in the United written comments by July 19, 2016. ADDRESSES: You may submit comments submit a comment with confidential States. information that you do not wish to be as follows: From July 1 through July 5, 2016, the made publicly available, submit your Federal eRulemaking Portal, http:// Electronic Submissions comments only as a written/paper www.regulations.gov, is undergoing Submit electronic comments in the submission. You should submit two maintenance. We are, therefore, following way: copies total. One copy will include the extending the comment period for • Federal eRulemaking Portal: http:// information you claim to be confidential commenting on the information www.regulations.gov. Follow the with a heading or cover note that states collection provisions of the Agency’s instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS regulations that require registration for Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The domestic and foreign facilities that including attachments, to http:// Agency will review this copy, including manufacture, process, pack, or hold www.regulations.gov will be posted to the claimed confidential information, in the docket unchanged. Because your its consideration of comments. The food for human or animal consumption comment will be made public, you are second copy, which will have the in the United States. The extended solely responsible for ensuring that your claimed confidential information comment period will close on July 12, comment does not include any redacted/blacked out, will be available 2016. for public viewing and posted on http:// confidential information that you or a Dated: June 24, 2016. third party may not wish to be posted, www.regulations.gov. Submit both Leslie Kux, such as medical information, your or copies to the Division of Dockets Associate Commissioner for Policy. anyone else’s Social Security number, or Management. If you do not wish your [FR Doc. 2016–15475 Filed 6–29–16; 8:45 am] confidential business information, such name and contact information to be as a manufacturing process. Please note made publicly available, you can mstockstill on DSK3G9T082PROD with NOTICES BILLING CODE 4164–01–P that if you include your name, contact provide this information on the cover information, or other information that sheet and not in the body of your identifies you in the body of your comments and you must identify this comments, that information will be information as ‘‘confidential.’’ Any posted on http://www.regulations.gov. information marked as ‘‘confidential’’ • If you want to submit a comment will not be disclosed except in with confidential information that you accordance with 21 CFR 10.20 and other VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1


Document Created: 2018-02-08 07:44:51
Document Modified: 2018-02-08 07:44:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; extension of comment period.
DatesFDA is extending the comment period on the notice published May 5, 2016 (81 FR 27140). Submit either electronic or written comments by July 12, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 42713 
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