82 FR 58004 - Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 235 (December 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 58004-58005 | |
| FR Document | 2017-26436 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 58004-58005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26436] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5767] Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS.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 of availability that appeared in the Federal Register of October 3, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' The Agency is taking this action in response to public interest in the draft guidance and to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice of availability published October 3, 2017 (82 FR 46075). Submit either electronic or written comments on the draft guidance by February 4, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 58005]] 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-2017-D-5767 for ``Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability.'' 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.'' 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 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. FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1672, Silver Spring, MD 20993-0002, 301-796-9291, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of October 3, 2017, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the submission of ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866. Based on public interest in the draft guidance, FDA is extending the comment period for the notice of availability for 60 days, until February 4, 2018. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26436 Filed 12-7-17; 8:45 am] BILLING CODE 4164-01-P
![58004 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
301–796–1125, email: Tamy.Kim@ Therefore, you should always check the DEPARTMENT OF HEALTH AND
fda.hhs.gov. FDA’s Oncology Center of Excellence HUMAN SERVICES
Web site at https://www.fda.gov/
I. Background Food and Drug Administration
aboutfda/centersoffices/officeofmedical
FDA announces the establishment of productsandtobacco/oce/
a public docket and a public listening [Docket No. FDA–2017–D–5767]
ucm544496.htm and scroll down to the
session for the OCE. As a part of 21st appropriate meeting link.
Century Cures Act (Cures Act), section Abbreviated New Drug Applications for
3073, the ‘‘Secretary shall establish one III. Participating in the Public Meeting Certain Highly Purified Synthetic
or more Intercenter Institutes within the Registration: To register for the public Peptide Drug Products That Refer to
Agency for a major disease area or meeting, persons interested in attending Listed Drugs of Recombinant
areas’’ and ‘‘shall provide a period for this public meeting must register online Deoxyribonucleic Acid Origin; Draft
public comment during the time that by February 15, 2018. Please visit the Guidance for Industry; Availability;
each Institute is being implemented’’ following Web site to register: https:// Extension of Comment Period
(section 1014 of the Federal Food, Drug, fdaoce.formstack.com/forms/ AGENCY: Food and Drug Administration,
and Cosmetic Act (FD&C Act) (21 U.S.C. ocelisteningsession. Please provide HHS.
399g)). The OCE is the Agency’s first complete contact information for each ACTION:Notice of availability; extension
Intercenter Institute. attendee, including name, title,
Under the Cures Act, the purpose of of comment period.
affiliation, address, email, and
an Intercenter Institute is to coordinate telephone. SUMMARY: The Food and Drug
activities among FDA Centers, Registration is free and based on Administration (FDA or Agency) is
applicable to the major disease area, space availability, with priority given to extending the comment period for the
including coordination of staff, early registrants. Persons interested in notice of availability that appeared in
streamlining of review activities, attending this public meeting must the Federal Register of October 3, 2017.
promotion of scientific programs, staff register by February 15, 2018, midnight In the notice of availability, FDA
recruitment and development, Eastern Time. Early registration is requested comments on the draft
enhancement of interactions, and recommended because seating is guidance for industry entitled ‘‘ANDAs
facilitation of collaborative relationships limited; therefore, FDA may limit the for Certain Highly Purified Synthetic
within the Department of Health and number of participants from each Peptide Drug Products That Refer to
Human Services. organization. Registrants will receive Listed Drugs of rDNA Origin.’’ The
FDA is establishing a docket for confirmation when they have been Agency is taking this action in response
public comment for written comments accepted. to public interest in the draft guidance
and will hold a listening session for If you need special accommodations and to allow interested persons
parties who are interested in due to a disability, please contact Tamy additional time to submit comments.
commenting verbally. This will serve as Kim (see FOR FURTHER INFORMATION
DATES: FDA is extending the comment
the public comment period identified CONTACT) no later than March 1, 2018.
under the Cures Act (section 1014(b) of period on the notice of availability
Requests for Oral Presentations:
the FD&C Act). published October 3, 2017 (82 FR
During online registration you may
46075). Submit either electronic or
II. Topics for Discussion at the Public indicate if you wish to present during a
written comments on the draft guidance
Meeting public comment session, and which
by February 4, 2018, to ensure that the
topic(s) you wish to address. We will do
The docket for public comments and Agency considers your comment on this
our best to accommodate requests.
public listening session will discuss the draft guidance before it begins work on
Individuals and organizations with
structure, function, regulatory purview, the final version of the guidance.
common interests are urged to
and activities of the OCE and solicit consolidate or coordinate their ADDRESSES: You may submit comments
comments regarding how the public presentations, and request time for a on any guidance at any time as follows:
would like the OCE to be structured and joint presentation. Following the close Electronic Submissions
what function the OCE should serve as of registration, we will determine the
an Intercenter Institute. amount of time allotted to each Submit electronic comments in the
The public docket and listening presenter and the approximate time following way:
session are intended to be a part of the each oral presentation is to begin, and • Federal eRulemaking Portal:
period of public comment during the will select and notify participants by https://www.regulations.gov. Follow the
implementation of the Oncology Center March 1, 2018. All requests to make oral instructions for submitting comments.
of Excellence, the first Intercenter presentations must be received by the Comments submitted electronically,
Institute at FDA. FDA intends to make close of registration on February 15, including attachments, to https://
background material available to the 2018. If selected for presentation, any www.regulations.gov will be posted to
public no later than 2 business days presentation materials must be emailed the docket unchanged. Because your
before the meeting. If FDA is unable to to Tamy Kim (see FOR FURTHER comment will be made public, you are
post the background material on its Web INFORMATION CONTACT) no later than solely responsible for ensuring that your
site prior to the meeting, the background March 12, 2018. No commercial or comment does not include any
material will be made publicly available promotional material will be permitted confidential information that you or a
at the location of the meeting, and the third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES
to be presented or distributed at the
background material will be posted on public meeting. such as medical information, your or
FDA’s Web site after the meeting. A anyone else’s Social Security number, or
notice in the Federal Register about last Dated: December 4, 2017. confidential business information, such
minute modifications that impact a Leslie Kux, as a manufacturing process. Please note
previously announced meeting detail Associate Commissioner for Policy. that if you include your name, contact
cannot always be published quickly [FR Doc. 2017–26440 Filed 12–7–17; 8:45 am] information, or other information that
enough to provide timely notice. BILLING CODE 4164–01–P identifies you in the body of your
VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\08DEN1.SGM 08DEN1](https://thefederalregister.org/doc/82_FR_58239/page/1.svg)
![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 58005
comments, that information will be except in accordance with 21 CFR 10.20 DEPARTMENT OF HEALTH AND
posted on https://www.regulations.gov. and other applicable disclosure law. For HUMAN SERVICES
• If you want to submit a comment more information about FDA’s posting
with confidential information that you of comments to public dockets, see 80 National Institutes of Health
do not wish to be made available to the FR 56469, September 18, 2015, or access
public, submit the comment as a the information at: https://www.gpo.gov/ Request for Information on the Office
written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- of Disease Prevention Strategic Plan
manner detailed (see ‘‘Written/Paper 23389.pdf. for Fiscal Years (FY) 2019–2023
Submissions’’ and ‘‘Instructions’’). AGENCY: National Institutes of Health,
Docket: For access to the docket to
Written/Paper Submissions read background documents or the HHS.
Submit written/paper submissions as electronic and written/paper comments ACTION: Notice.
follows: received, go to https://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the SUMMARY: This Request for Information
written/paper submissions): Dockets docket number, found in brackets in the (RFI) is intended to gather broad public
Management Staff (HFA–305), Food and heading of this document, into the input on the FY 2019–2023 Strategic
Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Plan for the Office of Disease Prevention
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management (ODP) in the Division of Program
• For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061, Coordination, Planning, and Strategic
submitted to the Dockets Management Rockville, MD 20852. Initiatives (DPCPSI), National Institutes
Staff, FDA will post your comment, as of Health (NIH). The ODP invites input
well as any attachments, except for FOR FURTHER INFORMATION CONTACT: Gail from prevention researchers in
information submitted, marked and Schmerfeld, Office of Generic Drugs, academia and industry, health care
identified, as confidential, if submitted Center for Drug Evaluation and professionals, patient advocates and
as detailed in ‘‘Instructions.’’ Research, Food and Drug advocacy organizations, scientific or
Instructions: All submissions received Administration, 10903 New Hampshire professional organizations, federal
must include the Docket No. FDA– Ave., Bldg. 75, Rm. 1672, Silver Spring, agencies, and other interested members
2017–D–5767 for ‘‘Abbreviated New MD 20993–0002, 301–796–9291, of the public. Organizations are strongly
Drug Applications for Certain Highly Gail.Schmerfeld@fda.hhs.gov. encouraged to submit a single response
Purified Synthetic Peptide Drug SUPPLEMENTARY INFORMATION: In the that reflects the views of their
Products That Refer to Listed Drugs of Federal Register of October 3, 2017, organization and membership as a
Recombinant Deoxyribonucleic Acid FDA published a notice of availability whole.
Origin; Draft Guidance for Industry; with a 60-day comment period to DATES: The ODP’s Request for
Availability.’’ Received comments will request comments on the draft guidance Information is open for public comment
be placed in the docket and, except for for industry entitled ‘‘ANDAs for for a period of 45 days. Comments must
those submitted as ‘‘Confidential Certain Highly Purified Synthetic be received by January 22, 2018 to
Submissions,’’ publicly viewable at Peptide Drug Products That Refer to ensure consideration.
https://www.regulations.gov or at the Listed Drugs of rDNA Origin.’’ ADDRESSES: Comments must be
Dockets Management Staff between 9
This draft guidance is being issued submitted electronically using the web-
a.m. and 4 p.m., Monday through
consistent with FDA’s good guidance based form available at https://
Friday.
• Confidential Submissions—To practices regulation (21 CFR 10.115). prevention.nih.gov/strategic-plan/
submit a comment with confidential The draft guidance, when finalized, will request-for-information.
information that you do not wish to be represent the current thinking of FDA FOR FURTHER INFORMATION CONTACT:
made publicly available, submit your on the submission of ANDAs for certain Please direct all inquiries to Wilma
comments only as a written/paper highly purified synthetic peptide drug Peterman Cross, M.S.; Deputy Director,
submission. You should submit two products that refer to listed drugs of Office of Disease Prevention, National
copies total. One copy will include the rDNA origin. It does not establish any Institutes of Health; Phone: 301–827–
information you claim to be confidential rights for any person and is not binding 5561; email: prevention@mail.nih.gov.
with a heading or cover note that states on FDA or the public. You can use an SUPPLEMENTARY INFORMATION: To ensure
‘‘THIS DOCUMENT CONTAINS alternative approach if it satisfies the consideration, responses must be
CONFIDENTIAL INFORMATION.’’ The requirements of the applicable statutes submitted electronically using the web-
Agency will review this copy, including and regulations. This draft guidance is based form available at https://
the claimed confidential information, in not subject to Executive Order 12866. prevention.nih.gov/strategic-plan/
its consideration of comments. The Based on public interest in the draft request-for-information. The web form
second copy, which will have the guidance, FDA is extending the will provide confirmation of response
claimed confidential information comment period for the notice of submission, but respondents will not
redacted/blacked out, will be available availability for 60 days, until February receive individualized feedback. All
for public viewing and posted on 4, 2018. The Agency believes that a 60- respondents are encouraged to sign up
https://www.regulations.gov. Submit day extension allows adequate time for for the ODP email list at http://
both copies to the Dockets Management interested persons to submit comments prevention.nih.gov/subscribe to receive
Staff. If you do not wish your name and without significantly delaying guidance information related to Office activities,
sradovich on DSK3GMQ082PROD with NOTICES
contact information to be made publicly on these important issues. including updates on the development
available, you can provide this Dated: December 4, 2017. and release of the final strategic plan.
information on the cover sheet and not The mission of the Office of Disease
Leslie Kux,
in the body of your comments and you Prevention (ODP) is to improve the
must identify this information as Associate Commissioner for Policy. public health by increasing the scope,
‘‘confidential.’’ Any information marked [FR Doc. 2017–26436 Filed 12–7–17; 8:45 am] quality, dissemination, and impact of
as ‘‘confidential’’ will not be disclosed BILLING CODE 4164–01–P prevention research supported by the
VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\08DEN1.SGM 08DEN1](https://thefederalregister.org/doc/82_FR_58239/page/2.svg)
Document Created: 2017-12-08 01:43:45
Document Modified: 2017-12-08 01:43:45
| 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 on the notice of availability published October 3, 2017 (82 FR 46075). Submit either electronic or written comments on the draft guidance by February 4, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Gail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1672, Silver Spring, MD 20993-0002, 301-796-9291, [email protected] | |
| FR Citation | 82 FR 58004 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR