81 FR 36313 - Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 108 (June 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 108 (June 6, 2016)
| Page Range | 36313-36314 | |
| FR Document | 2016-13223 |
[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)] [Notices] [Pages 36313-36314] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13223] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0643] Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Labeling for Biosimilar Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016.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.'' [[Page 36314]] Instructions: All submissions received must include the Docket No. FDA-2016-D-0643 for ``Labeling for Biosimilar Products; Draft Guidance for Industry; Availability.'' 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 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. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of April 4, 2016 (81 FR 19194), FDA published a notice with a 60-day comment period to request comments on the draft guidance for industry entitled ``Labeling for Biosimilar Products.'' FDA is extending the comment period for an additional 60 days, until August 2, 2016. The Agency believes that a 60-day extension will allow adequate time for interested persons to submit comments without compromising timely publication of the final guidance. II. Electronic Access Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. Dated: May 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13223 Filed 6-3-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices 36313
355(j)(7)), which requires FDA to was withdrawn from sale for reasons of petitions for such a determination under
publish a list of all approved drugs. safety or effectiveness (21 CFR 314.162). 21 CFR 10.25(a) and 10.30. Section
FDA publishes this list as part of the Under § 314.161(a) (21 CFR 314.161(d) provides that if FDA
‘‘Approved Drug Products With 314.161(a)), the Agency must determine determines that a listed drug was
Therapeutic Equivalence Evaluations,’’ whether a listed drug was withdrawn withdrawn from sale for safety or
which is generally known as the from sale for reasons of safety or effectiveness reasons, the Agency will
‘‘Orange Book.’’ Under FDA regulations, effectiveness: (1) Before an ANDA that initiate proceedings that could result in
a drug is removed from the list if the refers to that listed drug may be the withdrawal of approval of the
Agency withdraws or suspends approved, (2) whenever a listed drug is ANDAs that refer to the listed drug.
approval of the drug’s NDA or ANDA voluntarily withdrawn from sale and FDA has become aware that the drug
for reasons of safety or effectiveness, or ANDAs that refer to the listed drug have products listed in the following table are
if FDA determines that the listed drug been approved, and (3) when a person no longer being marketed.
Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
NDA 008303 .......... APRESOLINE ...... Hydralazine Hydrochloride; 20 milligrams (mg)/milliliter Injectable; Injection Tablet; Novartis Pharmaceuticals
10 mg; 25 mg; 50 mg; Oral. Corp.
100 mg.
NDA 017853 .......... PROVENTIL ......... Albuterol Sulfate .................. Equivalent to (EQ) 2 mg Tablet; Oral .......................... Schering-Plough Corp.
base; EQ 4 mg base.
NDA 019439 .......... K-Dur .................... Potassium Chloride ............. 10 milliequivalents (meq); 20 Extended-Release Tablet; Merck Sharp & Dohme,
meq. Oral. Corp.
ANDA 060572 ....... MYCOLOG–II ....... Nystatin; Triamcinolone 100,000 units/gram; 0.1% ... Ointment; Topical ................ Delcor Asset Corp.
Acetonide.
ANDA 084343 ....... KENALOG ............ Triamcinolone Acetonide ..... 0.025%; 0.1% ...................... Lotion; Topical ..................... Delcor Asset Corp.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND instructions for submitting comments.
under § 314.161, has determined that HUMAN SERVICES Comments submitted electronically,
the drug products listed in this including attachments, to http://
document were not withdrawn from Food and Drug Administration www.regulations.gov will be posted to
sale for reasons of safety or [Docket No. FDA–2016–D–0643] the docket unchanged. Because your
effectiveness. Accordingly, the Agency comment will be made public, you are
will continue to list the drug products Labeling for Biosimilar Products; Draft solely responsible for ensuring that your
listed in this document in the Guidance for Industry; Availability; comment does not include any
‘‘Discontinued Drug Product List’’ Extension of Comment Period confidential information that you or a
section of the Orange Book. The third party may not wish to be posted,
AGENCY: Food and Drug Administration, such as medical information, your or
‘‘Discontinued Drug Product List’’ HHS.
identifies, among other items, drug anyone else’s Social Security number, or
ACTION:Notice of availability; extension confidential business information, such
products that have been discontinued of comment period. as a manufacturing process. Please note
from marketing for reasons other than
that if you include your name, contact
safety or effectiveness. SUMMARY: The Food and Drug
information, or other information that
Approved ANDAs that refer to the Administration (FDA or Agency) is
identifies you in the body of your
NDAs and ANDAs listed in this extending the comment period for the
comments, that information will be
notice entitled ‘‘Labeling for Biosimilar
document are unaffected by the posted on http://www.regulations.gov.
Products; Draft Guidance for Industry;
discontinued marketing of the products
Availability’’ that appeared in the • If you want to submit a comment
subject to those NDAs and ANDAs. with confidential information that you
Federal Register of April 4, 2016. The
Additional ANDAs that refer to these Agency is taking this action to allow do not wish to be made available to the
products may also be approved by the interested persons additional time to public, submit the comment as a
Agency if they comply with relevant submit comments. written/paper submission and in the
legal and regulatory requirements. If manner detailed (see ‘‘Written/Paper
DATES: FDA is extending the comment
FDA determines that labeling for these Submissions’’ and ‘‘Instructions’’).
period for the notice that published on
drug products should be revised to meet April 4, 2016 (81 FR 19194) by an Written/Paper Submissions
current standards, the Agency will additional 60 days. Although you can
advise ANDA applicants to submit such comment on any guidance at any time Submit written/paper submissions as
labeling. (see 21 CFR 10.115(g)(5)), to permit the follows:
Dated: May 31, 2016. Agency to consider your comments • Mail/Hand delivery/Courier (for
before issuing the final version of the written/paper submissions): Division of
Leslie Kux,
guidance, submit either electronic or Dockets Management (HFA–305), Food
Associate Commissioner for Policy. and Drug Administration, 5630 Fishers
written comments on the draft guidance
[FR Doc. 2016–13181 Filed 6–3–16; 8:45 am] Lane, Rm. 1061, Rockville, MD 20852.
by August 2, 2016.
BILLING CODE 4164–01–P • For written/paper comments
sradovich on DSK3TPTVN1PROD with NOTICES
ADDRESSES: You may submit comments
as follows: submitted to the Division of Dockets
Management, FDA will post your
Electronic Submissions comment, as well as any attachments,
Submit electronic comments in the except for information submitted,
following way: marked and identified, as confidential,
• Federal eRulemaking Portal: http:// if submitted as detailed in
www.regulations.gov. Follow the ‘‘Instructions.’’
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![36314 Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices
Instructions: All submissions received Biologics Evaluation and Research, The meeting will be closed to the
must include the Docket No. FDA– Food and Drug Administration, 10903 public in accordance with the
2016–D–0643 for ‘‘Labeling for New Hampshire Ave., Bldg. 71, Rm. provisions set forth in sections
Biosimilar Products; Draft Guidance for 3128, Silver Spring, MD 20993–0002. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Industry; Availability.’’ Received Send one self-addressed adhesive label as amended. The grant applications and
comments will be placed in the docket to assist that office in processing your the discussions could disclose
and, except for those submitted as requests. See the SUPPLEMENTARY confidential trade secrets or commercial
‘‘Confidential Submissions,’’ publicly INFORMATION section for electronic property such as patentable material,
viewable at http://www.regulations.gov access to the draft guidance document. and personal information concerning
or at the Division of Dockets FOR FURTHER INFORMATION CONTACT: individuals associated with the grant
Management between 9 a.m. and 4 p.m., Sandra Benton, Center for Drug applications, the disclosure of which
Monday through Friday. Evaluation and Research, Food and would constitute a clearly unwarranted
• Confidential Submissions—To Drug Administration, 10903 New invasion of personal privacy.
submit a comment with confidential Name of Committee: Arthritis and
Hampshire Ave., Bldg. 51, Rm. 6340,
information that you do not wish to be Musculoskeletal and Skin Diseases Initial
Silver Spring, MD 20993–0002, 301–
made publicly available, submit your Review Group; Arthritis and Musculoskeletal
796–1042; or Stephen Ripley, Center for
comments only as a written/paper and Skin Diseases Special Grants Review
Biologics Evaluation and Research, Committee.
submission. You should submit two
Food and Drug Administration, 10903 Date: June 16–17, 2016.
copies total. One copy will include the
New Hampshire Ave., Bldg. 71, Rm. Time: 7:00 p.m. to 5:00 p.m.
information you claim to be confidential
7301, Silver Spring, MD 20993–0002, Agenda: To review and evaluate grant
with a heading or cover note that states
240–402–7911. applications.
‘‘THIS DOCUMENT CONTAINS Place: Bethesda North Marriott Hotel &
CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
Conference Center, 5701 Marinelli Rd.,
Agency will review this copy, including I. Background Bethesda, MD 20852.
the claimed confidential information, in Contact Person: Helen Lin, Ph.D.,
its consideration of comments. The In the Federal Register of April 4, Scientific Review Officer, NIH/NIAMS/RB,
second copy, which will have the 2016 (81 FR 19194), FDA published a 6701 Democracy Blvd., Suite 800, Plaza One,
claimed confidential information notice with a 60-day comment period to Bethesda, MD 20817, 301–594–4952, linh1@
request comments on the draft guidance mail.nih.gov.
redacted/blacked out, will be available
for public viewing and posted on http:// for industry entitled ‘‘Labeling for (Catalogue of Federal Domestic Assistance
Biosimilar Products.’’ FDA is extending Program Nos. 93.846, Arthritis,
www.regulations.gov. Submit both
the comment period for an additional 60 Musculoskeletal and Skin Diseases Research,
copies to the Division of Dockets National Institutes of Health, HHS)
Management. If you do not wish your days, until August 2, 2016. The Agency
name and contact information to be believes that a 60-day extension will Dated: May 27, 2016.
made publicly available, you can allow adequate time for interested Sylvia L. Neal,
provide this information on the cover persons to submit comments without Program Analyst, Office of Federal Advisory
sheet and not in the body of your compromising timely publication of the Committee Policy.
comments and you must identify this final guidance. [FR Doc. 2016–13200 Filed 6–3–16; 8:45 am]
information as ‘‘confidential.’’ Any II. Electronic Access
BILLING CODE 4140–01–P
information marked as ‘‘confidential’’
will not be disclosed except in Persons with access to the Internet
accordance with 21 CFR 10.20 and other may obtain the draft guidance at http:// DEPARTMENT OF HEALTH AND
applicable disclosure law. For more www.fda.gov/Drugs/Guidance HUMAN SERVICES
information about FDA’s posting of ComplianceRegulatoryInformation/
comments to public dockets, see 80 FR Guidances/default.htm, http:// National Institutes of Health
56469, September 18, 2015, or access www.fda.gov/BiologicsBloodVaccines/ Center for Scientific Review; Notice of
the information at: http://www.fda.gov/ GuidanceComplianceRegulatory Closed Meetings
regulatoryinformation/dockets/ Information/Guidances/default.htm, or
default.htm. http://www.regulations.gov. Pursuant to section 10(d) of the
Docket: For access to the docket to Dated: May 31, 2016. Federal Advisory Committee Act, as
read background documents or the amended (5 U.S.C. App.), notice is
Leslie Kux,
electronic and written/paper comments hereby given of the following meetings.
Associate Commissioner for Policy. The meetings will be closed to the
received, go to http://
www.regulations.gov and insert the [FR Doc. 2016–13223 Filed 6–3–16; 8:45 am] public in accordance with the
docket number, found in brackets in the BILLING CODE 4164–01–P provisions set forth in sections
heading of this document, into the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
‘‘Search’’ box and follow the prompts as amended. The grant applications and
and/or go to the Division of Dockets DEPARTMENT OF HEALTH AND the discussions could disclose
Management, 5630 Fishers Lane, Rm. HUMAN SERVICES confidential trade secrets or commercial
1061, Rockville, MD 20852. property such as patentable material,
Submit written requests for single National Institutes of Health
and personal information concerning
copies of the draft guidance to the individuals associated with the grant
sradovich on DSK3TPTVN1PROD with NOTICES
National Institute of Arthritis and
Division of Drug Information, Center for Musculoskeletal and Skin Diseases; applications, the disclosure of which
Drug Evaluation and Research, Food Notice of Closed Meeting would constitute a clearly unwarranted
and Drug Administration, 10001 New invasion of personal privacy.
Hampshire Ave., Hillandale Building, Pursuant to section 10(d) of the Name of Committee: Center for Scientific
4th Floor, Silver Spring, MD 20993– Federal Advisory Committee Act, as Review Special Emphasis Panel; Member
0002; or the Office of Communication, amended (5 U.S.C. App.), notice is Conflicts and Continuous Submission:
Outreach and Development, Center for hereby given of the following meeting. Ischemia and HDL.
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Document Created: 2016-06-04 00:16:41
Document Modified: 2016-06-04 00:16:41
| 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 period. | |
| Dates | FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016. | |
| Contact | Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 81 FR 36313 |
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