83 FR 58583 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 224 (November 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 224 (November 20, 2018)
| Page Range | 58583-58585 | |
| FR Document | 2018-25232 |
[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)] [Notices] [Pages 58583-58585] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25232] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-N-0129] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 20, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0719. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., [[Page 58584]] North Bethesda, MD 20852, 301-796-3794, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. General Licensing Provisions; Section 351(k) Biosimilar Applications OMB Control Number 0910-0719--Extension The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. Section 351(k) defines biosimilarity to mean that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that ``there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product'' (see section 351(i)(2) of the PHS Act). A 351(k) application must contain, among other things, information demonstrating that the biological product is biosimilar to a reference product based upon data derived from analytical studies, animal studies, and clinical studies, unless FDA determines, in its discretion, that certain studies are unnecessary in a 351(k) application (see section 351(k)(2) of the PHS Act). To meet the standard for interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch (see section 351(k)(4) of the PHS Act). Interchangeable products may be substituted for the reference product without the intervention of the prescribing healthcare provider (see section 351(i)(3) of the PHS Act) In estimating the information collection burden for 351(k) biosimilar product applications and interchangeable product applications or supplements, we reviewed the number of 351(k) applications FDA has received in fiscal years 2015, 2016, and 2017, considered responses to a survey of biosimilar sponsors and applicants regarding projected future 351(k) submission volumes, as well as the collection of information regarding the general licensing provisions for biologics license applications under section 351(a) of the PHS Act submitted to OMB (approved under OMB control number 0910- 0338). To submit an application seeking licensure of a proposed biosimilar product under sections 351(k)(2)(A)(i) and (iii) of the PHS Act, the estimated burden hours (FDA believes) would be approximately the same as noted under OMB control number 0910-0338 for a 351(a) application-- 860 hours. The burden estimates for seeking licensure of a proposed biosimilar product that meets the standards for interchangeability under sections 351(k)(2)(B) and (k)(4) would also be 860 hours per application. FDA believes these estimates are appropriate for 351(k) applications because the paperwork burden for a 351(k) application is expected to be comparable to the paperwork burden for a 351(a) application. In addition to the collection of information regarding the submission of a 351(k) application for a proposed biosimilar or interchangeable biological product, section 351(l) of the BPCI Act establishes procedures for identifying and resolving patent disputes involving applications submitted under section 351(k) of the PHS Act. The burden estimate for the patent notification provisions under section 351(l)(6)(C) of the BPCI Act are included in table 1 and are based on the estimated number of 351(k) applicants. Based on similar reporting requirements, FDA estimates this notification will take 2 hours. In the Federal Register of July 3, 2018 (83 FR 31152), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 351(k) Applications (42 U.S.C. Number of responses per Total annual burden per Total hours 262(k)) respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 351(k)(2)(A)(i) and 4 2.25 9 860 7,740 351(k)(2)(A)(iii) Biosimilar Product Applications........... 351(k)(2)(B) and (k)(4) 2 1 2 860 1,720 Interchangeable Product Applications or Supplements.... 351(l)(6)(C) Patent Infringement 4 2.25 9 2 18 Notifications.................. ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 9,478 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 58585]] Based on a review of the information collection since our last request for OMB approval, the estimated burden for the information collection reflects an overall increase in total hours and responses. We attribute this adjustment to an increase in the number of submissions received over the last few years and additional interest in the biosimilars program. Dated: November 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25232 Filed 11-19-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices 58583
revenue. The survey will be standards employed across the identified in the published literature
administered by web or by mail cosmetics industry. With regard to any systematic, detailed study of the
(respondent choice) and it will be identifying manufacturers who are not diversity of the practices and standards
directed to the Plant Manager of the observing good manufacturing practices, employed across the cosmetic industry
cosmetics establishment. the survey is structured to provide FDA to ensure product quality and safety.’’
This is a new, one-time data with anonymized, updated cosmetic FDA is conducting this survey to fill
collection. FDA does not plan to collect industry information, not individual this gap in knowledge, and this survey
this data from the cosmetics industry on response information about any of its is necessary to achieve this goal. With
an ongoing basis. participants. regard to the survey itself, it is (and has
In the Federal Register of July 2, 2018 The second comment addressed been) available at the FDA Docket
(83 FR 30940), FDA published a 60-day specific PRA issues of necessity, burden assigned to this collection (FDA–2018–
notice requesting public comment on estimate, quality and utility of the N–2027). We agree that the burden is
the proposed collection of information. survey, and method of collection. The likely greater than 30 minutes, and
FDA received three comments. FDA commenter feels that the survey is not based on results of our pretest with six
thanks the commenters for their necessary for proper FDA oversight of individuals, we have increased the
comments and provides our responses the industry because this information is burden estimate to 60 minutes. FDA’s
below. already available to FDA through its contractor did consult with industry
The first comment expressed concern facility inspections. They also indicated stakeholders in the development of the
that the collection was voluntary, and a that they had not seen the actual survey instrument. Finally, FDA thanks
number of manufacturers may not questions on the survey, and therefore the commenter for their comments and
participate, which will not inform FDA felt the burden estimate was not thoughts that our suggested method of
of manufacturers who are not observing feasible. They suggested that FDA web or collection method was
good manufacturing practices. They also partner with outside sources to assist reasonable.
indicated that they feel the survey could FDA in gathering information about the
help set future standards for the industry and thought that web or mail The third comment was not related to
industry. In response to this comment, collection was reasonable. the PRA and will not be addressed at
FDA notes that this survey is being In response to the second comment, this time.
conducted to inform FDA with updated FDA noted in the Federal Register of FDA estimates the burden of this
information about the practices and July 2, 2018 that FDA has ‘‘not collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
Survey Invitation .......................................................... 898 1 898 0.08 (5 minutes) ..... 71.84
Survey .......................................................................... 564 1 564 1 ............................. 564
Total ...................................................................... ........................ ........................ ........................ ................................ 635.84
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We will select a sample of 898 Dated: November 14, 2018. information has been submitted to the
establishments. After adjusting for Leslie Kux, Office of Management and Budget
ineligibility (i.e., firms that do not Associate Commissioner for Policy. (OMB) for review and clearance under
produce cosmetic products and those no [FR Doc. 2018–25231 Filed 11–19–18; 8:45 am] the Paperwork Reduction Act of 1995.
longer in operation) and a response rate BILLING CODE 4164–01–P DATES: Fax written comments on the
of 70 percent, we expect 564 completed collection of information by December
surveys. 20, 2018.
We expect each individual survey DEPARTMENT OF HEALTH AND
HUMAN SERVICES ADDRESSES: To ensure that comments on
invitation to take 5 minutes (0.08 hour)
the information collection are received,
to complete. Multiplying by the 898
Food and Drug Administration OMB recommends that written
establishments that will receive the
[Docket No. FDA 2012–N–0129]
comments be faxed to the Office of
survey invitation, we estimate the time
Information and Regulatory Affairs,
burden of the survey invitation to be
Agency Information Collection OMB, Attn: FDA Desk Officer, Fax: 202–
71.84 hours. Previously, we estimated
Activities; Submission for Office of 395–7285, or emailed to oira_
that the survey would take 30 minutes submission@omb.eop.gov. All
to complete. However, based on our Management and Budget Review;
Comment Request; General Licensing comments should be identified with the
pretest with six individuals, we now OMB control number 0910–0719. Also
expect each individual survey to take, Provisions; Section 351(k) Biosimilar
Applications include the FDA docket number found
on average, 60 minutes (1 hour) to in brackets in the heading of this
complete. Multiplying by the estimated AGENCY: Food and Drug Administration, document.
564 establishments that will complete HHS.
the survey, we estimate the time burden ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
of the survey to be 564 hours. We JonnaLynn Capezzuto, Office of
estimate the total hourly reporting SUMMARY: The Food and Drug Operations, Food and Drug
burden for this collection of information Administration (FDA) is announcing Administration, Three White Flint
to be 635.84 hours. that a proposed collection of North, 10A–12M, 11601 Landsdown St.,
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![Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices 58585
Based on a review of the information 1capapp.com/event/ismicc/ or by Congress and any other relevant federal
collection since our last request for joining the teleconference at the toll- department or agency.
OMB approval, the estimated burden for free, dial-in number at 1–800–369–3143;
II. Membership
the information collection reflects an passcode 4784259.
overall increase in total hours and The public comment section is This ISMICC consists of federal
responses. We attribute this adjustment scheduled for 1:00 p.m. Eastern Daylight members listed below or their
to an increase in the number of Time (EDT), and individuals interested designees, and non-federal public
submissions received over the last few in submitting a comment, must notify members.
years and additional interest in the the Designated Federal Official, Ms. Federal Membership: Members
biosimilars program. Pamela Foote, on or before November include, The Secretary of Health and
26, 2018 via email to: Pamela.Foote@ Human Services; The Assistant
Dated: November 14, 2018.
samhsa.hhs.gov. Secretary for Mental Health and
Leslie Kux,
Two minutes will be allotted for each Substance Use; The Attorney General;
Associate Commissioner for Policy. The Secretary of the Department of
approved public comment as time
[FR Doc. 2018–25232 Filed 11–19–18; 8:45 am] Veterans Affairs; The Secretary of the
permits. Written comments received in
BILLING CODE 4164–01–P
advance of the meeting will be included Department of Defense; The Secretary of
in the official record of the meeting. the Department of Housing and Urban
Substantive meeting information and Development; The Secretary of the
DEPARTMENT OF HEALTH AND Department of Education; The Secretary
a roster of Committee members is
HUMAN SERVICES of the Department of Labor; The
available at the Committee’s website
https://www.samhsa.gov/about-us/ Administrator of the Centers for
Substance Abuse and Mental Health
advisory-councils/smi-committee. Medicare and Medicaid Services; and
Services Administration
The Commissioner of the Social
SUPPLEMENTARY INFORMATION:
Notice of Meeting for the Security Administration.
Interdepartmental Serious Mental I. Background and Authority Non-federal Membership: Members
Illness Coordinating Committee The ISMICC was established on include, 14 non-federal public members
(ISMICC) March 15, 2017, in accordance with appointed by the Secretary, representing
section 6031 of the 21st Century Cures psychologists, psychiatrists, social
AGENCY: Substance Abuse and Mental workers, peer support specialists, and
Act, and the Federal Advisory
Health Services Administration, other providers, patients, family of
Committee Act, 5 U.S.C. App., as
Department of Health and Human patients, law enforcement, the judiciary,
amended, to report to the Secretary,
Services. and leading research, advocacy, or
Congress, and any other relevant federal
ACTION: Notice.
department or agency on advances in service organizations. The ISMICC is
serious mental illness (SMI) and serious required to meet at least twice per year.
SUMMARY: The Secretary of Health and
emotional disturbance (SED), research FOR FURTHER INFORMATION CONTACT:
Human Services (Secretary) announces
related to the prevention of, diagnosis Pamela Foote, Substance Abuse and
a meeting of the Interdepartmental
of, intervention in, and treatment and Mental Health Services Administration,
Serious Mental Illness Coordinating
recovery of SMIs, SEDs, and advances in 5600 Fishers Lane, 14E53C, Rockville,
Committee (ISMICC).
The ISMICC is open to the public and access to services and support for adults MD 20857; telephone: 240–276–1279;
members of the public can attend the with SMI or children with SED. In email: pamela.foote@samhsa.hhs.gov.
meeting via telephone or webcast only, addition, the ISMICC will evaluate the Dated: November 15, 2018.
and not in person. Call-in information effect federal programs related to serious Carlos Castillo,
will be posted on the ISMICC website mental illness have on public health, Committee Management Officer.
prior to the meeting, under the agenda including public health outcomes such [FR Doc. 2018–25310 Filed 11–19–18; 8:45 am]
section. as (A) rates of suicide, suicide attempts, BILLING CODE 4162–20–P
The meeting will include information incidence and prevalence of SMIs,
on federal efforts related to serious SEDs, and substance use disorders,
mental illness (SMI) and serious overdose, overdose deaths, emergency
DEPARTMENT OF HOMELAND
emotional disturbance (SED), including hospitalizations, emergency room
SECURITY
federal coordination, strategies, data boarding, preventable emergency room
evaluation, and recommendations for visits, interaction with the criminal Coast Guard
action. Committee members will also justice system, homelessness, and
discuss federal implementation of unemployment; (B) increased rates of [Docket No. USCG–2018–1044]
ISMICC recommendations. employment and enrollment in
educational and vocational programs; Information Collection Request to
The ISMICC will conduct five
(C) quality of mental and substance use Office of Management and Budget;
breakout sessions on the following focus
disorders treatment services; or (D) any OMB Control Number: 1625–0103
areas: Data, Access, Treatment and
Recovery, Justice, and Finance. other criteria as may be determined by AGENCY:Coast Guard, DHS.
Committee name: Interdepartmental the Secretary. Finally, the ISMICC will Sixty-day notice requesting
ACTION:
Serious Mental Illness Coordinating make specific recommendations for comments.
Committee. actions that agencies can take to better
Date/Time/Type: December 11, 2018/ coordinate the administration of mental SUMMARY: In compliance with the
9:00 a.m.–5:00 p.m. (EDT)/OPEN. health services for adults with SMI or Paperwork Reduction Act of 1995, the
ADDRESSES: The meeting will be held at children with SED. Not later than 1 U.S. Coast Guard intends to submit an
SAMHSA Headquarters, 5600 Fishers (one) year after the date of enactment of Information Collection Request (ICR) to
Lane, Rockville, Maryland 20857. the 21st Century Cures Act, and 5 (five) the Office of Management and Budget
The meeting can be accessed via years after such date of enactment, the (OMB), Office of Information and
webcast at https://2020archive. ISMICC shall submit a report to Regulatory Affairs (OIRA), requesting an
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Document Created: 2018-11-20 07:59:34
Document Modified: 2018-11-20 07:59:34
| 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. | |
| Dates | Fax written comments on the collection of information by December 20, 2018. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 83 FR 58583 |
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