81 FR 59640 - 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Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Extension of Comment Periods
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 168 (August 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 168 (August 30, 2016)
| Page Range | 59640-59641 | |
| FR Document | 2016-20780 |
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)] [Notices] [Pages 59640-59641] From the Federal Register Online [www.thefederalregister.org] [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Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment periods for the Draft Guidance entitled, ``Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods''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 DATES: We are extending the comment periods on the draft guidance published June 2, 2016 (81 FR 35363).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: 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-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 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 [[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: 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: 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
![59640 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices
appropriate advisory committee meeting DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
link. HUMAN SERVICES that if you include your name, contact
Procedure: Interested persons may information, or other information that
Food and Drug Administration identifies you in the body of your
present data, information, or views,
[Docket No. FDA–2014–D–0055] comments, that information will be
orally or in writing, on issues pending
posted on http://www.regulations.gov.
before the committee. Written • If you want to submit a comment
submissions may be made to the contact Voluntary Sodium Reduction Goals:
Target Mean and Upper Bound with confidential information that you
person on or before October 21, 2016. do not wish to be made available to the
Concentrations for Sodium in
Oral presentations from the public will public, submit the comment as a
Commercially Processed, Packaged,
be scheduled between approximately and Prepared Foods; Draft Guidance written/paper submission and in the
1:30 p.m. and 2:30 p.m. Those for Industry; Extension of Comment manner detailed (see ‘‘Written/Paper
individuals interested in making formal Periods Submissions’’ and ‘‘Instructions’’).
oral presentations should notify the
AGENCY: Food and Drug Administration, Written/Paper Submissions
contact person and submit a brief
statement of the general nature of the HHS. Submit written/paper submissions as
evidence or arguments they wish to ACTION:Notice of availability; extension follows:
present, the names and addresses of of comment periods. • Mail/Hand delivery/Courier (for
proposed participants, and an written/paper submissions): Division of
SUMMARY: The Food and Drug Dockets Management (HFA–305), Food
indication of the approximate time Administration (FDA or we) is and Drug Administration, 5630 Fishers
requested to make their presentation on extending the comment periods for the Lane, Rm. 1061, Rockville, MD 20852.
or before October 13, 2016. Time Draft Guidance entitled, ‘‘Voluntary • For written/paper comments
allotted for each presentation may be Sodium Reduction Goals: Target Mean submitted to the Division of Dockets
limited. If the number of registrants and Upper Bound Concentrations for Management, FDA will post your
requesting to speak is greater than can Sodium in Commercially Processed, comment, as well as any attachments,
be reasonably accommodated during the Packaged, and Prepared Foods’’ that except for information submitted,
scheduled open public hearing session, appeared in the Federal Register of June marked and identified, as confidential,
FDA may conduct a lottery to determine 2, 2016. In the notice, we requested if submitted as detailed in
the speakers for the scheduled open comments on developing the sodium ‘‘Instructions.’’
public hearing session. The contact targets and for implementation of the Instructions: All submissions received
person will notify interested persons guidance document. We are taking this must include the Docket No. FDA–
regarding their request to speak by action in response to requests to extend 2014–D–0055 for ‘‘Voluntary Sodium
October 14, 2016. the two comment periods to allow Reduction Goals: Target Mean and
interested persons additional time to Upper Bound Concentrations for
Persons attending FDA’s advisory submit comments. Sodium in Commercially Processed,
committee meetings are advised that the Packaged, and Prepared Foods; Draft
DATES: We are extending the comment
Agency is not responsible for providing Guidance for Industry.’’ Received
periods on the draft guidance published
access to electrical outlets. June 2, 2016 (81 FR 35363). Submit comments will be placed in the docket
FDA welcomes the attendance of the either electronic or written comments and, except for those submitted as
public at its advisory committee on Issues 1 through 4 in section IV of ‘‘Confidential Submissions,’’ publicly
meetings and will make every effort to the notice of availability that published viewable at http://www.regulations.gov
accommodate persons with disabilities. on June 2, 2016, by October 17, 2016. or at the Division of Dockets
If you require accommodations due to a Submit either electronic or written Management between 9 a.m. and 4 p.m.,
disability, please contact Lauren D. Tesh comments on Issues 5 through 8 in Monday through Friday.
at least 7 days in advance of the section IV of the notice of availability • Confidential Submissions—To
meeting. that published on June 2, 2016, by submit a comment with confidential
December 2, 2016. information that you do not wish to be
FDA is committed to the orderly made publicly available, submit your
ADDRESSES: You may submit comments
conduct of its advisory committee comments only as a written/paper
as follows:
meetings. Please visit our Web site at submission. You should submit two
http://www.fda.gov/ Electronic Submissions copies total. One copy will include the
AdvisoryCommittees/ Submit electronic comments in the information you claim to be confidential
AboutAdvisoryCommittees/ following way: with a heading or cover note that states
ucm111462.htm for procedures on • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
public conduct during advisory www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
committee meetings. instructions for submitting comments. Agency will review this copy, including
Notice of this meeting is given under Comments submitted electronically, the claimed confidential information, in
the Federal Advisory Committee Act (5 including attachments, to http:// its consideration of comments. The
U.S.C. app. 2). www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
Dated: August 25, 2016. comment will be made public, you are redacted/blacked out, will be available
mstockstill on DSK3G9T082PROD with NOTICES
Leslie Kux, solely responsible for ensuring that your for public viewing and posted on http://
Associate Commissioner for Policy. comment does not include any www.regulations.gov. Submit both
[FR Doc. 2016–20765 Filed 8–29–16; 8:45 am] confidential information that you or a copies to the Division of Dockets
BILLING CODE 4164–01–P
third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
anyone else’s Social Security number, or made publicly available, you can
confidential business information, such provide this information on the cover
VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1](https://thefederalregister.org/doc/81_FR_59808/page/1.svg)
![Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices 59641
sheet and not in the body of your goals, and to address FDA requirements. officer for HRSA, either by email to
comments and you must identify this The requested extensions would result OIRA_submission@omb.eop.gov or by
information as ‘‘confidential.’’ Any in a 180-day comment period for all fax to 202–395–5806.
information marked as ‘‘confidential’’ eight Issues for Consideration. We also FOR FURTHER INFORMATION CONTACT: To
will not be disclosed except in received comments opposed to any request a copy of the clearance requests
accordance with 21 CFR 10.20 and other extensions of the comment period submitted to OMB for review, email the
applicable disclosure law. For more related to the short-term goals. These HRSA Information Collection Clearance
information about FDA’s posting of comments expressed their view that the Officer at paperwork@hrsa.gov or call
comments to public dockets, see 80 FR initial comment period provided (301) 443–1984.
56469, September 18, 2015, or access sufficient time for stakeholders to SUPPLEMENTARY INFORMATION:
the information at: http://www.fda.gov/ review the draft guidance and to Information Collection Request Title:
regulatoryinformation/dockets/ contribute informed comments and that The Stem Cell Therapeutic Outcomes
default.htm. it is important for FDA to move forward Database OMB No. 0915–0310—
Docket: For access to the docket to in finalizing the short-term goals for Revision.
read background documents or the public health reasons. Abstract: The Stem Cell Therapeutic
electronic and written/paper comments We considered the requests and are and Research Act of 2005, Public Law
received, go to http:// extending the comment periods for the (P.L.) 109–129, as amended by the Stem
www.regulations.gov and insert the draft guidance as follows: For Issues 1 Cell Therapeutic and Research
docket number, found in brackets in the through 4, we are extending the Reauthorization Act of 2015, P.L. 114–
heading of this document, into the comment period until October 17, 2016, 104 (the Act), provides for the collection
‘‘Search’’ box and follow the prompts and for Issues 5 through 8 we are and maintenance of human blood stem
and/or go to the Division of Dockets extending the comment period until cells for the treatment of patients and
Management, 5630 Fishers Lane, Rm. December 2, 2016. We believe that these research. HRSA’s Healthcare Systems
1061, Rockville, MD 20852. extensions allow adequate time for Bureau established the Stem Cell
FOR FURTHER INFORMATION CONTACT: interested persons to submit comments Therapeutic Outcomes Database.
Kasey Heintz, Center for Food Safety without significantly delaying finalizing Operation of this database necessitates
and Applied Nutrition (HFS–255), Food the guidance. certain record keeping and reporting
and Drug Administration, 5001 Campus Dated: August 25, 2016. requirements to perform the functions
Dr., College Park, MD 20740, 240–402– Leslie Kux, related to hematopoietic stem cell
1376. Associate Commissioner for Policy. transplantation under contract to the
SUPPLEMENTARY INFORMATION: In the [FR Doc. 2016–20780 Filed 8–29–16; 8:45 am] U.S. Department of Health and Human
Federal Register of June 2, 2016 (81 FR BILLING CODE 4164–01–P
Services (HHS). The Act requires the
35363), we published a notice Secretary to contract for the
announcing the availability of a draft establishment and maintenance of
guidance entitled, ‘‘Voluntary Sodium DEPARTMENT OF HEALTH AND information related to patients who
Reduction Goals: Target Mean and HUMAN SERVICES received stem cell therapeutic products
Upper Bound Concentrations for and to do so using a standardized,
Sodium in Commercially Processed, Health Resources and Services electronic format. Data is collected from
Packaged, and Prepared Foods.’’ Section Administration transplant centers by the Center for
IV of the notice, ‘‘Issues for International Blood and Marrow
Consideration,’’ listed eight specific Agency Information Collection Transplant Research and is used for
questions (or ‘‘issues’’) and provided Activities: Submission to OMB for ongoing analysis of transplant
two comment periods for the Review and Approval; Public Comment outcomes. Post-Transplant Essential
submission of comments pertaining to Request; The Stem Cell Therapeutic Data (TED) forms are being revised in
these issues (81 FR 35363 at 35366). The Outcomes Database this submission. The portion of the
comment period for Issues related Product Form related to confirmation of
AGENCY: Health Resources and Services
primarily to short-term goals (Issues 1 human leukocyte antigen (HLA) typing
Administration, HHS
through 4) was scheduled to end on has minor changes to the identification
August 31, 2016, and the comment ACTION: Notice
and date fields to allow this form to
period for issues related primarily to SUMMARY: In compliance with Section more flexibly capture HLA typing data
long-term goals (Issues 5 through 8) was 3507(a)(1)(D) of the Paperwork for expanding indications of cellular
scheduled to end on October 31, 2016. Reduction Act of 1995, the Health therapy. The Pre-TED form remains
Comments on Issues 1 through 8 will Resources and Services Administration unchanged from the previously
inform our final guidance on the (HRSA) has submitted an Information approved OMB submission.
voluntary sodium reduction goals. Collection Request (ICR) to the Office of The increase in burden is due to an
We received requests for 90- and 30- Management and Budget (OMB) for increase in the annual number of
day extensions of these comment review and approval. Comments transplants and increasing survivorship
periods, respectively. In general, the submitted during the first public review after transplantation.
requests expressed concern that the of this ICR will be provided to OMB. Need and Proposed Use of the
current 90- and 150-day comment OMB will accept further comments from Information: HRSA uses the information
periods do not allow sufficient time to to carry out its statutory responsibilities.
mstockstill on DSK3G9T082PROD with NOTICES
the public during the review and
develop a meaningful or thoughtful approval period. Information is needed to monitor the
response to the draft guidance. Some clinical status of transplantation and
DATES: Comments on this ICR should be
requests mentioned a need for provide the Secretary of HHS with an
companies to review the sodium received no later than September 29, annual report of transplant center
concentration in their products, to 2016. specific survival data.
consider what technology might be ADDRESSES: Submit your comments, Likely Respondents: Transplant
needed to meet the sodium reduction including the ICR Title, to the desk Centers.
VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1](https://thefederalregister.org/doc/81_FR_59808/page/2.svg)
Document Created: 2018-02-09 11:42:19
Document Modified: 2018-02-09 11:42:19
| 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 of availability; extension of comment periods. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 59640 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR