Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Extension of Comment Periods, 59640-59641 [2016-20780]

Download as PDF 59640 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 21, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 13, 2016. Time allotted for each presentation may be limited. 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Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–20765 Filed 8–29–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0055] Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment periods. ACTION: The Food and Drug Administration (FDA or we) is extending the comment periods for the Draft Guidance entitled, ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods’’ that appeared in the Federal Register of June 2, 2016. In the notice, we requested comments on developing the sodium targets and for implementation of the guidance document. We are taking this action in response to requests to extend the two comment periods to allow interested persons additional time to submit comments. DATES: We are extending the comment periods on the draft guidance published June 2, 2016 (81 FR 35363). Submit either electronic or written comments on Issues 1 through 4 in section IV of the notice of availability that published on June 2, 2016, by October 17, 2016. Submit either electronic or written comments on Issues 5 through 8 in section IV of the notice of availability that published on June 2, 2016, by December 2, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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): 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– 2014–D–0055 for ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 https:// 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 E:\FR\FM\30AUN1.SGM 30AUN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices 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.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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kasey Heintz, Center for Food Safety and Applied Nutrition (HFS–255), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 1376. SUPPLEMENTARY INFORMATION: In the Federal Register of June 2, 2016 (81 FR 35363), we published a notice announcing the availability of a draft guidance entitled, ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.’’ Section IV of the notice, ‘‘Issues for Consideration,’’ listed eight specific questions (or ‘‘issues’’) and provided two comment periods for the submission of comments pertaining to these issues (81 FR 35363 at 35366). The comment period for Issues related primarily to short-term goals (Issues 1 through 4) was scheduled to end on August 31, 2016, and the comment period for issues related primarily to long-term goals (Issues 5 through 8) was scheduled to end on October 31, 2016. Comments on Issues 1 through 8 will inform our final guidance on the voluntary sodium reduction goals. We received requests for 90- and 30day extensions of these comment periods, respectively. In general, the requests expressed concern that the current 90- and 150-day comment periods do not allow sufficient time to develop a meaningful or thoughtful response to the draft guidance. Some requests mentioned a need for companies to review the sodium concentration in their products, to consider what technology might be needed to meet the sodium reduction VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 goals, and to address FDA requirements. The requested extensions would result in a 180-day comment period for all eight Issues for Consideration. We also received comments opposed to any extensions of the comment period related to the short-term goals. These comments expressed their view that the initial comment period provided sufficient time for stakeholders to review the draft guidance and to contribute informed comments and that it is important for FDA to move forward in finalizing the short-term goals for public health reasons. We considered the requests and are extending the comment periods for the draft guidance as follows: For Issues 1 through 4, we are extending the comment period until October 17, 2016, and for Issues 5 through 8 we are extending the comment period until December 2, 2016. We believe that these extensions allow adequate time for interested persons to submit comments without significantly delaying finalizing the guidance. Dated: August 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–20780 Filed 8–29–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Stem Cell Therapeutic Outcomes Database Health Resources and Services Administration, HHS ACTION: Notice AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than September 29, 2016. SUMMARY: Submit your comments, including the ICR Title, to the desk ADDRESSES: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 59641 officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database OMB No. 0915–0310— Revision. Abstract: The Stem Cell Therapeutic and Research Act of 2005, Public Law (P.L.) 109–129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2015, P.L. 114– 104 (the Act), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. HRSA’s Healthcare Systems Bureau established the Stem Cell Therapeutic Outcomes Database. Operation of this database necessitates certain record keeping and reporting requirements to perform the functions related to hematopoietic stem cell transplantation under contract to the U.S. Department of Health and Human Services (HHS). The Act requires the Secretary to contract for the establishment and maintenance of information related to patients who received stem cell therapeutic products and to do so using a standardized, electronic format. Data is collected from transplant centers by the Center for International Blood and Marrow Transplant Research and is used for ongoing analysis of transplant outcomes. Post-Transplant Essential Data (TED) forms are being revised in this submission. The portion of the Product Form related to confirmation of human leukocyte antigen (HLA) typing has minor changes to the identification and date fields to allow this form to more flexibly capture HLA typing data for expanding indications of cellular therapy. The Pre-TED form remains unchanged from the previously approved OMB submission. The increase in burden is due to an increase in the annual number of transplants and increasing survivorship after transplantation. Need and Proposed Use of the Information: HRSA uses the information to carry out its statutory responsibilities. Information is needed to monitor the clinical status of transplantation and provide the Secretary of HHS with an annual report of transplant center specific survival data. Likely Respondents: Transplant Centers. E:\FR\FM\30AUN1.SGM 30AUN1

Agencies

[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59640-59641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20780]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0055]


Voluntary Sodium Reduction Goals: Target Mean and Upper Bound 
Concentrations for Sodium in Commercially Processed, Packaged, and 
Prepared Foods; Draft Guidance for Industry; Extension of Comment 
Periods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment periods.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment periods for the Draft Guidance entitled, ``Voluntary Sodium 
Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium 
in Commercially Processed, Packaged, and Prepared Foods'' that appeared 
in the Federal Register of June 2, 2016. In the notice, we requested 
comments on developing the sodium targets and for implementation of the 
guidance document. We are taking this action in response to requests to 
extend the two comment periods to allow interested persons additional 
time to submit comments.

DATES: We are extending the comment periods on the draft guidance 
published June 2, 2016 (81 FR 35363). Submit either electronic or 
written comments on Issues 1 through 4 in section IV of the notice of 
availability that published on June 2, 2016, by October 17, 2016. 
Submit either electronic or written comments on Issues 5 through 8 in 
section IV of the notice of availability that published on June 2, 
2016, by December 2, 2016.

ADDRESSES: You may submit comments as follows:

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): 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-2014-D-0055 for ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods; Draft Guidance for Industry.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://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 https://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

[[Page 59641]]

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.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 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kasey Heintz, Center for Food Safety 
and Applied Nutrition (HFS-255), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1376.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 2, 2016 (81 
FR 35363), we published a notice announcing the availability of a draft 
guidance entitled, ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods.'' Section IV of the notice, ``Issues for 
Consideration,'' listed eight specific questions (or ``issues'') and 
provided two comment periods for the submission of comments pertaining 
to these issues (81 FR 35363 at 35366). The comment period for Issues 
related primarily to short-term goals (Issues 1 through 4) was 
scheduled to end on August 31, 2016, and the comment period for issues 
related primarily to long-term goals (Issues 5 through 8) was scheduled 
to end on October 31, 2016. Comments on Issues 1 through 8 will inform 
our final guidance on the voluntary sodium reduction goals.
    We received requests for 90- and 30-day extensions of these comment 
periods, respectively. In general, the requests expressed concern that 
the current 90- and 150-day comment periods do not allow sufficient 
time to develop a meaningful or thoughtful response to the draft 
guidance. Some requests mentioned a need for companies to review the 
sodium concentration in their products, to consider what technology 
might be needed to meet the sodium reduction goals, and to address FDA 
requirements. The requested extensions would result in a 180-day 
comment period for all eight Issues for Consideration. We also received 
comments opposed to any extensions of the comment period related to the 
short-term goals. These comments expressed their view that the initial 
comment period provided sufficient time for stakeholders to review the 
draft guidance and to contribute informed comments and that it is 
important for FDA to move forward in finalizing the short-term goals 
for public health reasons.
    We considered the requests and are extending the comment periods 
for the draft guidance as follows: For Issues 1 through 4, we are 
extending the comment period until October 17, 2016, and for Issues 5 
through 8 we are extending the comment period until December 2, 2016. 
We believe that these extensions allow adequate time for interested 
persons to submit comments without significantly delaying finalizing 
the guidance.

    Dated: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20780 Filed 8-29-16; 8:45 am]
BILLING CODE 4164-01-P
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