The Food and Drug Administration's Comprehensive, Multi-Year Nutrition Innovation Strategy; Extension of the Comment Period, 42513-42514 [2018-18072]

Download as PDF Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: August 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–18045 Filed 8–21–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–2381] The Food and Drug Administration’s Comprehensive, Multi-Year Nutrition Innovation Strategy; Extension of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; extension of the comment period. ACTION: The Food and Drug Administration (FDA or we) is extending the comment period for the notice of a public meeting and request for comments, published in the Federal Register of June 27, 2018. The notice announced a public meeting entitled ‘‘FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy’’ and invited interested parties to provide information on specific topics related to amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 16:34 Aug 21, 2018 Jkt 244001 FDA’s Nutrition Innovation Strategy. We are extending the comment period to give interested parties more time to comment. DATES: FDA is extending the comment period on the notice and its request for comment, published in the Federal Register of June 27, 2018 (83 FR 30180). Submit either electronic or written comments by October 11, 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 October 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time, October 11, 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 42513 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–2381 for ‘‘The Food and Drug Administration’s Comprehensive, MultiYear Nutrition Innovation Strategy; Public Meeting; Request for Comments.’’ 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.’’ 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. E:\FR\FM\22AUN1.SGM 22AUN1 42514 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices ensuring the continued forward progress of FDA’s Nutrition Innovation Strategy. FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Food and Drug Administration, Office of Foods and Veterinary Medicine, 10903 New Hampshire Ave., Bldg. 1, Rm. 3218, Silver Spring, MD 20993, 301–796– 4647. [FR Doc. 2018–18072 Filed 8–21–18; 8:45 am] In the Federal Register of June 27, 2018 (83 FR 30180), FDA announced that it would hold a public meeting entitled ‘‘FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy.’’ The public meeting, which we held on July 26, 2018, was intended to give interested persons an opportunity to discuss FDA’s Nutrition Innovation Strategy and to provide input on ways to modernize FDA’s approach to better protect public health while removing barriers to industry innovation. We stated that the topics to be addressed at the meeting would include the following: • Considering using a standard icon to denote the claim ‘‘healthy’’ on food labels. • Creating a more efficient review strategy for evaluating qualified health claims on food labels. • Discussing new or enhanced labeling statements or claims that could facilitate innovation to produce more healthful foods and more healthful consumer food choices. • Modernizing the standards of identity to provide more flexibility for the development of healthier products, while making sure consumers have accurate information about these food products. • Providing opportunities to make ingredient information more helpful to consumers. • FDA’s educational campaign for consumers about the updated Nutrition Facts label. See 83 FR 30180 at 30181 to 30182. The notice invited interested parties to provide information on these and other topics related to FDA’s Nutrition Innovation Strategy. We asked that comments be submitted on or before August 27, 2018. After the public meeting, we received several requests to extend the comment period. The requesters asserted that the time period of 32 days was insufficient to respond fully to FDA’s specific request for comments and to ensure comprehensive public input and allow potential respondents to thoroughly evaluate and address pertinent issues. We have considered the requests and are extending the comment period for another 45 days, until October 11, 2018. We believe that a 45-day extension allows adequate time for interested persons to submit comments while SUPPLEMENTARY INFORMATION: amozie on DSK3GDR082PROD with NOTICES1 Dated: August 16, 2018. Leslie Kux, Associate Commissioner for Policy. VerDate Sep<11>2014 16:34 Aug 21, 2018 Jkt 244001 BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–2999] Determination That DANOCRINE (Danazol) Capsules, 50 Milligrams, 100 Milligrams, and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Except the Indication of Fibrocystic Breast Disease, Which Was 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 DANOCRINE (danazol) Capsules, 50 milligrams (mg), 100 mg, and 200 mg, were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to suspend approval of abbreviated new drug applications (ANDAs) that refer to this drug product and have removed the indication for fibrocystic breast disease. This determination also will allow FDA to continue to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements. However, the Agency will not accept or approve ANDAs for DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg that include fibrocystic breast disease as an indication. 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 SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. Under § 314.161(a)(2), the Agency must also determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness if ANDAs that referred to the listed drug have already been approved prior to its market withdrawal. If the Agency determines that a listed drug was withdrawn from sale for reasons of safety or effectiveness, and there are approved ANDAs that reference that listed drug, FDA will initiate a proceeding to determine whether the suspension of the ANDAs is also required (§ 314.161(d)). DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg, is the subject of NDA 017557 held by Sanofi-Aventis, and initially approved on June 21, 1976. DANOCRINE is indicated for the treatment of endometriosis amenable to hormonal management, prevention of attacks of angioedema of all types (cutaneous, abdominal, and laryngeal) in males and females, and fibrocystic breast disease. Specifically, with respect to fibrocystic breast disease, the labeling states ‘‘Most cases of fibrocystic breast disease may be treated by simple E:\FR\FM\22AUN1.SGM 22AUN1

Agencies

[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42513-42514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18072]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2381]


The Food and Drug Administration's Comprehensive, Multi-Year 
Nutrition Innovation Strategy; Extension of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice of a public meeting and request for 
comments, published in the Federal Register of June 27, 2018. The 
notice announced a public meeting entitled ``FDA's Comprehensive, 
Multi-Year Nutrition Innovation Strategy'' and invited interested 
parties to provide information on specific topics related to FDA's 
Nutrition Innovation Strategy. We are extending the comment period to 
give interested parties more time to comment.

DATES: FDA is extending the comment period on the notice and its 
request for comment, published in the Federal Register of June 27, 2018 
(83 FR 30180). Submit either electronic or written comments by October 
11, 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 October 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time, October 11, 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-2381 for ``The Food and Drug Administration's Comprehensive, 
Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for 
Comments.'' 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.'' 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.

[[Page 42514]]


FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Food and Drug 
Administration, Office of Foods and Veterinary Medicine, 10903 New 
Hampshire Ave., Bldg. 1, Rm. 3218, Silver Spring, MD 20993, 301-796-
4647.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 27, 2018 (83 
FR 30180), FDA announced that it would hold a public meeting entitled 
``FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy.'' The 
public meeting, which we held on July 26, 2018, was intended to give 
interested persons an opportunity to discuss FDA's Nutrition Innovation 
Strategy and to provide input on ways to modernize FDA's approach to 
better protect public health while removing barriers to industry 
innovation. We stated that the topics to be addressed at the meeting 
would include the following:
     Considering using a standard icon to denote the claim 
``healthy'' on food labels.
     Creating a more efficient review strategy for evaluating 
qualified health claims on food labels.
     Discussing new or enhanced labeling statements or claims 
that could facilitate innovation to produce more healthful foods and 
more healthful consumer food choices.
     Modernizing the standards of identity to provide more 
flexibility for the development of healthier products, while making 
sure consumers have accurate information about these food products.
     Providing opportunities to make ingredient information 
more helpful to consumers.
     FDA's educational campaign for consumers about the updated 
Nutrition Facts label.
    See 83 FR 30180 at 30181 to 30182.
    The notice invited interested parties to provide information on 
these and other topics related to FDA's Nutrition Innovation Strategy. 
We asked that comments be submitted on or before August 27, 2018.
    After the public meeting, we received several requests to extend 
the comment period. The requesters asserted that the time period of 32 
days was insufficient to respond fully to FDA's specific request for 
comments and to ensure comprehensive public input and allow potential 
respondents to thoroughly evaluate and address pertinent issues.
    We have considered the requests and are extending the comment 
period for another 45 days, until October 11, 2018. We believe that a 
45-day extension allows adequate time for interested persons to submit 
comments while ensuring the continued forward progress of FDA's 
Nutrition Innovation Strategy.

    Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18072 Filed 8-21-18; 8:45 am]
 BILLING CODE 4164-01-P

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