83 FR 7060 - Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7060-7061 | |
| FR Document | 2018-03226 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7060-7061] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03226] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0077] Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Early Alzheimer's Disease: Developing Drugs for Treatment.'' This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This guidance revises the draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease'' issued February 8, 2013. DATES: Submit either electronic or written comments on the draft guidance by May 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: [[Page 7061]] 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-2013-D-0077 for ``Early Alzheimer's Disease: Developing Drugs for Treatment; 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. 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 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 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: Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4339, Silver Spring, MD 20993-0002, 301-796-2250; 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 FDA is announcing the availability of a draft guidance for industry entitled ``Early Alzheimer's Disease: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic AD that occur before the onset of overt dementia. This draft guidance revises the draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease'' issued February 8, 2013 (78 FR 9396), and reflects FDA's consideration of public comments on the draft guidance. This revision addresses FDA's current thinking regarding the selection of patients with early AD for enrollment into clinical trials and the selection of endpoints for clinical trials in these populations. 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 developing drugs for the treatment of early Alzheimer's disease. 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. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: February 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03226 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![7060 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
heading of this document, into the device had undergone a regulatory comply with all the requirements of
‘‘Search’’ box and follow the prompts review period and that the approval of § 60.30, including but not limited to:
and/or go to the Dockets Management HYMOVIS represented the first Must be timely (see DATES), Must be
Staff, 5630 Fishers Lane, Rm. 1061, permitted commercial marketing or use filed in accordance with § 10.20, must
Rockville, MD 20852. of the product. Thereafter, the USPTO contain sufficient facts to merit an FDA
FOR FURTHER INFORMATION CONTACT: requested that FDA determine the investigation, and must certify that a
Beverly Friedman, Office of Regulatory product’s regulatory review period. true and complete copy of the petition
Policy, Food and Drug Administration, II. Determination of Regulatory Review has been served upon the patent
10903 New Hampshire Ave., Bldg. 51, Period applicant. (See H. Rept. 857, part 1, 98th
Rm. 6250, Silver Spring, MD 20993, Cong., 2d sess., pp. 41–42, 1984.)
FDA has determined that the Petitions should be in the format
301–796–3600.
applicable regulatory review period for specified in 21 CFR 10.30.
SUPPLEMENTARY INFORMATION: HYMOVIS is 1,845 days. Of this time,
1,665 days occurred during the testing Submit petitions electronically to
I. Background
phase of the regulatory review period, https://www.regulations.gov at Docket
The Drug Price Competition and No. FDA–2013–S–0610. Submit written
while 180 days occurred during the
Patent Term Restoration Act of 1984 petitions (two copies are required) to the
approval phase. These periods of time
(Pub. L. 98–417) and the Generic Dockets Management Staff (HFA–305),
were derived from the following dates:
Animal Drug and Patent Term 1. The date an exemption under Food and Drug Administration, 5630
Restoration Act (Pub. L. 100–670) section 520(g) of the Federal Food, Drug, Fishers Lane, Rm. 1061, Rockville, MD
generally provide that a patent may be and Cosmetic Act (FD&C Act) (21 U.S.C. 20852.
extended for a period of up to 5 years 360j(g)) involving this device became Dated: February 12, 2018.
so long as the patented item (human effective: August 11, 2010. The Leslie Kux,
drug product, animal drug product, applicant claims that the investigational Associate Commissioner for Policy.
medical device, food additive, or color device exemption (IDE) required under
additive) was subject to regulatory [FR Doc. 2018–03229 Filed 2–15–18; 8:45 am]
section 520(g) of the FD&C Act for
review by FDA before the item was human tests to begin became effective
BILLING CODE 4164–01–P
marketed. Under these acts, a product’s on January 7, 2011. However, FDA
regulatory review period forms the basis records indicate that the IDE was
for determining the amount of extension DEPARTMENT OF HEALTH AND
determined substantially complete for HUMAN SERVICES
an applicant may receive. clinical studies to have begun on August
A regulatory review period consists of 11, 2010, which represents the IDE Food and Drug Administration
two periods of time: A testing phase and effective date.
an approval phase. For medical devices, 2. The date an application was
the testing phase begins with a clinical [Docket No. FDA–2013–D–0077]
initially submitted with respect to the
investigation of the device and runs device under section 515 of the FD&C Early Alzheimer’s Disease: Developing
until the approval phase begins. The Act (21 U.S.C. 360e): March 2, 2015. Drugs for Treatment; Draft Guidance
approval phase starts with the initial FDA has verified the applicant’s claim for Industry; Availability
submission of an application to market that the premarket approval application
the device and continues until (PMA) for HYMOVIS (PMA P150010) AGENCY: Food and Drug Administration,
permission to market the device is was initially submitted March 2, 2015. HHS.
granted. Although only a portion of a 3. The date the application was
regulatory review period may count approved: August 28, 2015. FDA has ACTION: Notice of availability.
toward the actual amount of extension verified the applicant’s claim that PMA
that the Director of USPTO may award P150010 was approved on August 28, SUMMARY: The Food and Drug
(half the testing phase must be 2015. Administration (FDA or Agency) is
subtracted as well as any time that may This determination of the regulatory announcing the availability of a draft
have occurred before the patent was review period establishes the maximum guidance for industry entitled ‘‘Early
issued), FDA’s determination of the potential length of a patent extension. Alzheimer’s Disease: Developing Drugs
length of a regulatory review period for However, the USPTO applies several for Treatment.’’ This guidance is
a medical device will include all of the statutory limitations in its calculations intended to assist sponsors in the
testing phase and approval phase as of the actual period for patent extension. clinical development of drugs for the
specified in 35 U.S.C. 156(g)(3)(B). In its application for patent extension, treatment of the stages of sporadic
FDA has approved for marketing the this applicant seeks 938 days of patent Alzheimer’s disease (AD) that occur
medical device HYMOVIS. HYMOVIS is term extension. before the onset of overt dementia. This
indicated for the treatment of pain in guidance revises the draft guidance for
osteoarthritis of the knee in patients III. Petitions industry entitled ‘‘Alzheimer’s Disease:
who have failed to respond adequately Anyone with knowledge that any of Developing Drugs for the Treatment of
to conservative non-pharmacologic the dates as published are incorrect may Early Stage Disease’’ issued February 8,
therapy and to simple analgesics. submit either electronic or written 2013.
Subsequent to this approval, the USPTO comments and, under 21 CFR 60.24, ask
DATES: Submit either electronic or
received a patent term restoration for a redetermination (see DATES).
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the draft guidance
application for HYMOVIS (U.S. Patent Furthermore, as specified in § 60.30 (21
by May 17, 2018 to ensure that the
No. 7,863,256) from Fidia Farmaceutici CFR 60.30), any interested person may
Agency considers your comment on this
S.p.A., and the USPTO requested FDA’s petition FDA for a determination
draft guidance before it begins work on
assistance in determining this patent’s regarding whether the applicant for
the final version of the guidance.
eligibility for patent term restoration. In extension acted with due diligence
a letter dated September 26, 2016, FDA during the regulatory review period. To ADDRESSES: You may submit comments
advised the USPTO that this medical meet its burden, the petition must on any guidance at any time as follows:
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![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7061
Electronic Submissions with a heading or cover note that states Drug Administration, 10903 New
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Hampshire Ave., Bldg. 71, Rm. 7301,
following way: CONFIDENTIAL INFORMATION.’’ The Silver Spring, MD 20993–0002, 240–
• Federal eRulemaking Portal: Agency will review this copy, including 402–7911.
https://www.regulations.gov. Follow the the claimed confidential information, in
its consideration of comments. The SUPPLEMENTARY INFORMATION:
instructions for submitting comments.
Comments submitted electronically, second copy, which will have the I. Background
including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available FDA is announcing the availability of
the docket unchanged. Because your for public viewing and posted on a draft guidance for industry entitled
comment will be made public, you are https://www.regulations.gov. Submit ‘‘Early Alzheimer’s Disease: Developing
solely responsible for ensuring that your both copies to the Dockets Management Drugs for Treatment.’’ This draft
comment does not include any Staff. If you do not wish your name and guidance is intended to assist sponsors
confidential information that you or a contact information to be made publicly in the clinical development of drugs for
third party may not wish to be posted, available, you can provide this the treatment of the stages of sporadic
such as medical information, your or information on the cover sheet and not AD that occur before the onset of overt
anyone else’s Social Security number, or in the body of your comments and you dementia. This draft guidance revises
confidential business information, such must identify this information as the draft guidance for industry entitled
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked ‘‘Alzheimer’s Disease: Developing Drugs
that if you include your name, contact as ‘‘confidential’’ will not be disclosed for the Treatment of Early Stage
information, or other information that except in accordance with 21 CFR 10.20 Disease’’ issued February 8, 2013 (78 FR
identifies you in the body of your and other applicable disclosure law. For
9396), and reflects FDA’s consideration
comments, that information will be more information about FDA’s posting
of public comments on the draft
posted on https://www.regulations.gov. of comments to public dockets, see 80
FR 56469, September 18, 2015, or access guidance. This revision addresses FDA’s
• If you want to submit a comment current thinking regarding the selection
with confidential information that you the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/2015- of patients with early AD for enrollment
do not wish to be made available to the into clinical trials and the selection of
public, submit the comment as a 23389.pdf.
Docket: For access to the docket to endpoints for clinical trials in these
written/paper submission and in the populations.
manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments This draft guidance is being issued
received, go to https:// consistent with FDA’s good guidance
Written/Paper Submissions www.regulations.gov and insert the practices regulation (21 CFR 10.115).
Submit written/paper submissions as docket number, found in brackets in the The draft guidance, when finalized, will
follows: heading of this document, into the represent the current thinking of FDA
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts on developing drugs for the treatment of
written/paper submissions): Dockets and/or go to the Dockets Management early Alzheimer’s disease. It does not
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, establish any rights for any person and
Drug Administration, 5630 Fishers Rockville, MD 20852. is not binding on FDA or the public.
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any You can use an alternative approach if
• For written/paper comments guidance at any time (see 21 CFR
it satisfies the requirements of the
submitted to the Dockets Management 10.115(g)(5)).
applicable statutes and regulations. This
Staff, FDA will post your comment, as Submit written requests for single
copies of the draft guidance to the draft guidance is not subject to
well as any attachments, except for Executive Order 12866.
information submitted, marked and Division of Drug Information, Center for
identified, as confidential, if submitted Drug Evaluation and Research, Food II. Electronic Access
as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New
Instructions: All submissions received Hampshire Ave., Hillandale Building, Persons with access to the internet
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– may obtain the draft guidance at https://
2013–D–0077 for ‘‘Early Alzheimer’s 0002, or Office of Communication, www.fda.gov/Drugs/Guidance
Disease: Developing Drugs for Outreach, and Development, Center for ComplianceRegulatoryInformation/
Treatment; Draft Guidance for Industry; Biologics Evaluation and Research, Guidances/default.htm, https://
Availability.’’ Received comments will Food and Drug Administration, 10903 www.fda.gov/BiologicsBloodVaccines/
be placed in the docket and, except for New Hampshire Ave., Bldg. 71, Rm. GuidanceComplianceRegulatory
those submitted as ‘‘Confidential 3128, Silver Spring, MD 20993–0002. Information/default.htm, or https://
Submissions,’’ publicly viewable at Send one self-addressed adhesive label www.regulations.gov.
https://www.regulations.gov or at the to assist that office in processing your
Dated: February 12, 2018.
Dockets Management Staff between 9 requests. See the SUPPLEMENTARY
INFORMATION section for electronic Leslie Kux,
a.m. and 4 p.m., Monday through
Friday. access to the draft guidance document. Associate Commissioner for Policy.
• Confidential Submissions—To FOR FURTHER INFORMATION CONTACT: [FR Doc. 2018–03226 Filed 2–15–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
submit a comment with confidential Billy Dunn, Center for Drug Evaluation BILLING CODE 4164–01–P
information that you do not wish to be and Research, Food and Drug
made publicly available, submit your Administration, 10903 New Hampshire
comments only as a written/paper Ave., Bldg. 22, Rm. 4339, Silver Spring,
submission. You should submit two MD 20993–0002, 301–796–2250; or
copies total. One copy will include the Stephen Ripley, Center for Biologics
information you claim to be confidential Evaluation and Research, Food and
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Document Created: 2018-02-16 00:55:44
Document Modified: 2018-02-16 00:55:44
| 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. | |
| Dates | Submit either electronic or written comments on the draft guidance by May 17, 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 | Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4339, Silver Spring, MD 20993-0002, 301-796-2250; 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 | 83 FR 7060 |
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