The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels: Draft Guidance for Industry; Availability, 16272-16273 [2019-07763]

Download as PDF 16272 Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity ANADA ..................................................... Phased Review with Administrative ANADA ................................................. Biowaiver request for soluble powder oral dosage form product, using same formulation/manufacturing process approach ................................................... Biowaiver request for soluble powder oral dosage form product, using same API/solubility approach ......................... Biowaiver request for Type A medicated article, using same formulation/manufacturing process approach .................. Biowaiver request for Type A medicated article, using same API/solubility approach ................................................... Total .................................................. jbell on DSK30RV082PROD with NOTICES 1 There Number of responses per respondent Number of respondents FDA Form No. Average burden per response Total annual responses Total hours 356v 18 1 18 159 2,862 356v 3 5 15 31.8 477 N/A 1 1 1 5 5 N/A 5 5 5 10 50 N/A 2 2 2 5 10 N/A 10 10 10 20 200 ........................ ........................ ........................ 51 ........................ 3,604 are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimates on our records of generic drug applications. We estimate that we will receive 21 ANADA submissions per year over the next 3 years and that three of those submissions will request phased review. We estimate that each applicant that uses the phased review process will have approximately five phased reviews per application. We estimate that an applicant will take approximately 159 hours to prepare either an ANADA or the estimated five ANADA phased review submissions and the administrative ANADA. Our estimates of the burden of biowaiver requests for generic soluble powder oral dosage form products and Type A medicated articles differ based on the type of product and the basis for the request, as shown in table 1. We estimate that an applicant will take between 5 and 20 hours to prepare a biowaiver request. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our previous estimate of the number of respondents submitting generic drug applications. However, as discussed, the burden for this information collection was increased by 265 hours and 18 responses since the last OMB approval. This is due to adding to this collection burden hours and responses for biowaiver requests. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: April 12, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. DATES: [FR Doc. 2019–07764 Filed 4–17–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:37 Apr 17, 2019 Jkt 247001 Food and Drug Administration [Docket No. FDA–2019–D–0725] The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels: Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ‘‘The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.’’ The draft guidance, when finalized, will provide guidance on the declaration of allulose on Nutrition Facts and Supplement Facts labels as well as on the caloric content of allulose. The draft guidance, when finalized, also would advise manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition Facts and Supplement Facts label and use of a general factor of 0.4 calories per gram (kcal/g) for allulose. SUMMARY: Submit either electronic or written comments on the draft guidance by June 17, 2019 to ensure that FDA considers your comment on the draft guidance before it begins work on the final version of the guidance. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 You may submit comments on any guidance at any time as follows: ADDRESSES: 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. E:\FR\FM\18APN1.SGM 18APN1 jbell on DSK30RV082PROD with NOTICES Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Notices • 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– 2019–D–0725 for ‘‘The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.’’ 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 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.’’ We will review this copy, including the claimed confidential information, in our 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. VerDate Sep<11>2014 17:37 Apr 17, 2019 Jkt 247001 You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1450. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ‘‘The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. The draft guidance is intended to provide guidance on the declaration of allulose on Nutrition Facts and Supplement Facts labels as well as on the caloric content of allulose. The draft guidance also would advise manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the label and use of a general factor of 0.4 kcal/g for allulose pending review of the issues in a rulemaking. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: April 12, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–07763 Filed 4–17–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 16273 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–3949] Determination That TRISENOX (Arsenic Trioxide) Injection, 1 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that TRISENOX (arsenic trioxide) injection, 1 milligram (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. SUMMARY: FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends E:\FR\FM\18APN1.SGM 18APN1

Agencies

[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16272-16273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07763]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0725]


The Declaration of Allulose and Calories From Allulose on 
Nutrition and Supplement Facts Labels: Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``The 
Declaration of Allulose and Calories from Allulose on Nutrition and 
Supplement Facts Labels.'' The draft guidance, when finalized, will 
provide guidance on the declaration of allulose on Nutrition Facts and 
Supplement Facts labels as well as on the caloric content of allulose. 
The draft guidance, when finalized, also would advise manufacturers of 
our intent to exercise enforcement discretion for the exclusion of 
allulose from the amount of Total Sugars and Added Sugars declared on 
the Nutrition Facts and Supplement Facts label and use of a general 
factor of 0.4 calories per gram (kcal/g) for allulose.

DATES: Submit either electronic or written comments on the draft 
guidance by June 17, 2019 to ensure that FDA considers your comment on 
the draft guidance before it begins work on the final version of the 
guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 16273]]

     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-2019-D-0725 for ``The Declaration of Allulose and Calories from 
Allulose on Nutrition and Supplement Facts Labels.'' 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 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.'' We will review 
this copy, including the claimed confidential information, in our 
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.gpo.gov/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``The Declaration of Allulose and Calories from Allulose on 
Nutrition and Supplement Facts Labels.'' We are issuing the draft 
guidance consistent with our good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent the current 
thinking of FDA on this topic. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternate approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.
    The draft guidance is intended to provide guidance on the 
declaration of allulose on Nutrition Facts and Supplement Facts labels 
as well as on the caloric content of allulose. The draft guidance also 
would advise manufacturers of our intent to exercise enforcement 
discretion for the exclusion of allulose from the amount of Total 
Sugars and Added Sugars declared on the label and use of a general 
factor of 0.4 kcal/g for allulose pending review of the issues in a 
rulemaking.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: April 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07763 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-P
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