83 FR 42513 - The Food and Drug Administration's Comprehensive, Multi-Year Nutrition Innovation Strategy; Extension of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 163 (August 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 163 (August 22, 2018)
| Page Range | 42513-42514 | |
| FR Document | 2018-18072 |
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)] [Notices] [Pages 42513-42514] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
![Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42513
product was withdrawn for reasons of FDA’s Nutrition Innovation Strategy. Staff, FDA will post your comment, as
safety or effectiveness. We have We are extending the comment period well as any attachments, except for
carefully reviewed our files for records to give interested parties more time to information submitted, marked and
concerning the withdrawal of comment. identified, as confidential, if submitted
DITROPAN XL (oxybutynin chloride) DATES: FDA is extending the comment as detailed in ‘‘Instructions.’’
Extended Release Tablets, 15 mg, from period on the notice and its request for Instructions: All submissions received
sale. We have also independently comment, published in the Federal must include the Docket No. FDA–
evaluated relevant literature and data Register of June 27, 2018 (83 FR 30180). 2018–N–2381 for ‘‘The Food and Drug
for possible postmarketing adverse Submit either electronic or written Administration’s Comprehensive, Multi-
events. We have found no information comments by October 11, 2018. Year Nutrition Innovation Strategy;
that would indicate that this drug ADDRESSES: You may submit comments Public Meeting; Request for Comments.’’
product was withdrawn from sale for as follows. Please note that late, Received comments, those filed in a
reasons of safety or effectiveness. untimely filed comments will not be timely manner (see ADDRESSES), will be
Accordingly, the Agency will considered. Electronic comments must placed in the docket and, except for
continue to list DITROPAN XL be submitted on or before October 11, those submitted as ‘‘Confidential
(oxybutynin chloride) Extended Release 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
Tablets, 15 mg, in the ‘‘Discontinued electronic filing system will accept https://www.regulations.gov or at the
Drug Product List’’ section of the Orange comments until midnight Eastern Time, Dockets Management Staff between 9
Book. The ‘‘Discontinued Drug Product October 11, 2018. Comments received a.m. and 4 p.m., Monday through
List’’ delineates, among other items, by mail/hand delivery/courier (for Friday.
drug products that have been written/paper submissions) will be
discontinued from marketing for reasons • Confidential Submissions—To
considered timely if they are submit a comment with confidential
other than safety or effectiveness. postmarked or the delivery service
ANDAs that refer to DITROPAN XL information that you do not wish to be
acceptance receipt is on or before that made publicly available, submit your
(oxybutynin chloride) Extended Release date.
Tablets, 15 mg, may be approved by the comments only as a written/paper
Agency as long as they meet all other Electronic Submissions submission. You should submit two
legal and regulatory requirements for Submit electronic comments in the copies total. One copy will include the
the approval of ANDAs. If FDA following way: information you claim to be confidential
determines that labeling for this drug • Federal eRulemaking Portal: with a heading or cover note that states
product should be revised to meet https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
current standards, the Agency will instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ We
advise ANDA applicants to submit such Comments submitted electronically, will review this copy, including the
labeling. including attachments, to https:// claimed confidential information, in our
Dated: August 15, 2018. www.regulations.gov will be posted to consideration of comments. The second
the docket unchanged. Because your copy, which will have the claimed
Leslie Kux,
comment will be made public, you are confidential information redacted/
Associate Commissioner for Policy. blacked out, will be available for public
[FR Doc. 2018–18045 Filed 8–21–18; 8:45 am] solely responsible for ensuring that your
comment does not include any viewing and posted on https://
BILLING CODE 4164–01–P
confidential information that you or a www.regulations.gov. Submit both
third party may not wish to be posted, copies to the Dockets Management Staff.
such as medical information, your or If you do not wish your name and
DEPARTMENT OF HEALTH AND contact information to be made publicly
HUMAN SERVICES anyone else’s Social Security number, or
confidential business information, such available, you can provide this
as a manufacturing process. Please note information on the cover sheet and not
Food and Drug Administration
that if you include your name, contact in the body of your comments and you
[Docket No. FDA–2018–N–2381]
information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
The Food and Drug Administration’s as ‘‘confidential’’ will not be disclosed
Comprehensive, Multi-Year Nutrition comments, that information will be
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Innovation Strategy; Extension of the and other applicable disclosure law. For
Comment Period • If you want to submit a comment
with confidential information that you more information about FDA’s posting
AGENCY: Food and Drug Administration, do not wish to be made available to the of comments to public dockets, see 80
HHS. public, submit the comment as a FR 56469, September 18, 2015, or access
written/paper submission and in the the information at: https://www.gpo.gov/
Notice; extension of the
ACTION:
fdsys/pkg/FR-2015-09-18/pdf/2015-
comment period. manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
SUMMARY: The Food and Drug Docket: For access to the docket to
Administration (FDA or we) is Written/Paper Submissions read background documents or the
extending the comment period for the Submit written/paper submissions as electronic and written/paper comments
notice of a public meeting and request follows: received, go to https://
amozie on DSK3GDR082PROD with NOTICES1
for comments, published in the Federal • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Register of June 27, 2018. The notice written/paper submissions): Dockets docket number, found in brackets in the
announced a public meeting entitled Management Staff (HFA–305), Food and heading of this document, into the
‘‘FDA’s Comprehensive, Multi-Year Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Nutrition Innovation Strategy’’ and Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
invited interested parties to provide • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
information on specific topics related to submitted to the Dockets Management Rockville, MD 20852.
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![42514 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
FOR FURTHER INFORMATION CONTACT: ensuring the continued forward progress must, with certain exceptions, show that
Claudine Kavanaugh, Food and Drug of FDA’s Nutrition Innovation Strategy. the drug for which they are seeking
Administration, Office of Foods and Dated: August 16, 2018. approval contains the same active
Veterinary Medicine, 10903 New Leslie Kux,
ingredient in the same strength and
Hampshire Ave., Bldg. 1, Rm. 3218, dosage form as the ‘‘listed drug,’’ which
Associate Commissioner for Policy.
Silver Spring, MD 20993, 301–796– is a version of the drug that was
[FR Doc. 2018–18072 Filed 8–21–18; 8:45 am] previously approved. ANDA applicants
4647.
BILLING CODE 4164–01–P do not have to repeat the extensive
SUPPLEMENTARY INFORMATION: In the
clinical testing otherwise necessary to
Federal Register of June 27, 2018 (83 FR
gain approval of a new drug application
30180), FDA announced that it would DEPARTMENT OF HEALTH AND (NDA).
hold a public meeting entitled ‘‘FDA’s HUMAN SERVICES The 1984 amendments include what
Comprehensive, Multi-Year Nutrition is now section 505(j)(7) of the Federal
Innovation Strategy.’’ The public Food and Drug Administration
Food, Drug, and Cosmetic Act (21 U.S.C.
meeting, which we held on July 26, [Docket No. FDA–2018–N–2999] 355(j)(7)), which requires FDA to
2018, was intended to give interested publish a list of all approved drugs.
persons an opportunity to discuss FDA’s Determination That DANOCRINE FDA publishes this list as part of the
Nutrition Innovation Strategy and to (Danazol) Capsules, 50 Milligrams, 100 ‘‘Approved Drug Products With
provide input on ways to modernize Milligrams, and 200 Milligrams, Were Therapeutic Equivalence Evaluations,’’
FDA’s approach to better protect public Not Withdrawn From Sale for Reasons which is known generally as the
health while removing barriers to of Safety or Effectiveness Except the ‘‘Orange Book.’’ Under FDA regulations,
industry innovation. We stated that the Indication of Fibrocystic Breast drugs are removed from the list if the
topics to be addressed at the meeting Disease, Which Was Withdrawn From Agency withdraws or suspends
would include the following: Sale for Reasons of Safety or approval of the drug’s NDA or ANDA
• Considering using a standard icon Effectiveness for reasons of safety or effectiveness or
to denote the claim ‘‘healthy’’ on food if FDA determines that the listed drug
labels. AGENCY: Food and Drug Administration,
was withdrawn from sale for reasons of
• Creating a more efficient review HHS.
safety or effectiveness (21 CFR 314.162).
strategy for evaluating qualified health ACTION: Notice. A person may petition the Agency to
claims on food labels. determine, or the Agency may
• Discussing new or enhanced SUMMARY: The Food and Drug
Administration (FDA or Agency) has determine on its own initiative, whether
labeling statements or claims that could a listed drug was withdrawn from sale
facilitate innovation to produce more determined that DANOCRINE (danazol)
Capsules, 50 milligrams (mg), 100 mg, for reasons of safety or effectiveness.
healthful foods and more healthful This determination may be made at any
consumer food choices. and 200 mg, were not withdrawn from
sale for reasons of safety or time after the drug has been withdrawn
• Modernizing the standards of from sale, but must be made prior to
identity to provide more flexibility for effectiveness, except with respect to the
indication of fibrocystic breast disease approving an ANDA that refers to the
the development of healthier products, listed drug (§ 314.161 (21 CFR 314.161)).
while making sure consumers have that was withdrawn for reasons of safety
or effectiveness. This determination FDA may not approve an ANDA that
accurate information about these food does not refer to a listed drug.
products. means that FDA will not begin
Under § 314.161(a)(2), the Agency
• Providing opportunities to make procedures to suspend approval of
must also determine whether a listed
ingredient information more helpful to abbreviated new drug applications drug was withdrawn from sale for
consumers. (ANDAs) that refer to this drug product reasons of safety or effectiveness if
• FDA’s educational campaign for and have removed the indication for ANDAs that referred to the listed drug
consumers about the updated Nutrition fibrocystic breast disease. This have already been approved prior to its
Facts label. determination also will allow FDA to market withdrawal. If the Agency
See 83 FR 30180 at 30181 to 30182. continue to approve ANDAs that refer to determines that a listed drug was
The notice invited interested parties this drug as long as they meet relevant withdrawn from sale for reasons of
to provide information on these and legal and regulatory requirements. safety or effectiveness, and there are
other topics related to FDA’s Nutrition However, the Agency will not accept or approved ANDAs that reference that
Innovation Strategy. We asked that approve ANDAs for DANOCRINE listed drug, FDA will initiate a
comments be submitted on or before (danazol) Capsules, 50 mg, 100 mg, and proceeding to determine whether the
August 27, 2018. 200 mg that include fibrocystic breast suspension of the ANDAs is also
After the public meeting, we received disease as an indication. required (§ 314.161(d)).
several requests to extend the comment FOR FURTHER INFORMATION CONTACT: DANOCRINE (danazol) Capsules, 50
period. The requesters asserted that the Stacy Kane, Center for Drug Evaluation mg, 100 mg, and 200 mg, is the subject
time period of 32 days was insufficient and Research, Food and Drug of NDA 017557 held by Sanofi-Aventis,
to respond fully to FDA’s specific Administration, 10903 New Hampshire and initially approved on June 21, 1976.
request for comments and to ensure Ave., Bldg. 51, Rm. 6236, Silver Spring, DANOCRINE is indicated for the
comprehensive public input and allow MD 20993–0002, 301–796–8363. treatment of endometriosis amenable to
potential respondents to thoroughly SUPPLEMENTARY INFORMATION: In 1984, hormonal management, prevention of
amozie on DSK3GDR082PROD with NOTICES1
evaluate and address pertinent issues. Congress enacted the Drug Price attacks of angioedema of all types
We have considered the requests and Competition and Patent Term (cutaneous, abdominal, and laryngeal)
are extending the comment period for Restoration Act of 1984 (Pub. L. 98–417) in males and females, and fibrocystic
another 45 days, until October 11, 2018. (the 1984 amendments), which breast disease. Specifically, with respect
We believe that a 45-day extension authorized the approval of duplicate to fibrocystic breast disease, the labeling
allows adequate time for interested versions of drug products under an states ‘‘Most cases of fibrocystic breast
persons to submit comments while ANDA procedure. ANDA applicants disease may be treated by simple
VerDate Sep<11>2014 16:34 Aug 21, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/83_FR_42676/page/2.svg)
Document Created: 2018-08-22 00:38:14
Document Modified: 2018-08-22 00:38:14
| 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; extension of the comment period. | |
| 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. | |
| 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 Citation | 83 FR 42513 |
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