81 FR 35367 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Nonproprietary Naming of Biological Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 106 (June 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 106 (June 2, 2016)
| Page Range | 35367-35368 | |
| FR Document | 2016-12885 |
[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)] [Notices] [Pages 35367-35368] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12885] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1543] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Nonproprietary Naming of Biological Products 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 July 5, 2016. 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-NEW and title ``Nonproprietary Naming of Biological Products.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Guidance for Industry on Nonproprietary Naming of Biological Products OMB Control Number 0910-NEW The guidance entitled ``Guidance for Industry on Nonproprietary Naming of Biological Products'' describes FDA's current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA- designated suffix. There is a need to clearly identify biological products to facilitate pharmacovigilance and, for the purposes of safe use, to minimize inadvertent substitution. Accordingly, for biological products licensed under the PHS Act, FDA intends to designate a nonproprietary name that includes a core name and a distinguishing suffix. This naming convention is applicable to biological products previously licensed and newly licensed under section 351(a) or 351(k) of the PHS Act (42 U.S.C. 262(a) or 262(k)). The guidance includes information collection by requesting that applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure for biological products licensed under the PHS Act. The suffix will be incorporated in the nonproprietary name of the product. The guidance recommends that applicants should submit up to 10 proposed suffixes, in the order of the applicant's preference. We also recommend including supporting analyses demonstrating that the proposed suffixes meet the factors described in the guidance for FDA's consideration. As indicated in table 1, we estimate that we will receive a total of 40 requests annually for the proposed proper name for biological products submitted under section 351(a) of the PHS Act, and 6 requests annually for the proposed proper name for biosimilar products and interchangeable products submitted under section 351(k) of the PHS Act. The average burden per response (hours) is based on our experience with similar information collection requirements for applicants to create and submit suffix proposals to FDA and in consideration of comments received in response to our 60-day notice. In the Federal Register of August 28, 2015 (80 FR 52296), we published a 60-day notice requesting public comment on the proposed collection of information. Most comments supported our proposal to designate a suffix. Many comments suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products. Some comments supported use of a random suffix to avoid creating an unfair advantage for specific manufacturers. Several comments stated that the current practices of FDA and non-FDA entities for identifying biosimilar and interchangeable products is sufficient for the purpose of pharmacovigilance, and designation of a suffix is not needed. One comment stated that FDA's estimate of 6 hours to submit proposed suffixes is based only on the time needed to prepare the submission itself after the multiple suffixes have been selected. The comment further stated that because FDA suggests that each respondent submit three suggested suffixes for consideration, the time needed to do an analysis of each suffix would exceed 720 hours per suffix (based on their own company experience) or 2,160 hours total for the three suffixes. In response to the comments we note that our estimated annual reporting burden results from information that would be submitted to us by applicants in order to facilitate Agency designation of a suffix as part of the proper name of a biological product. We estimated that sponsors would spend 2 hours completing the submission for each of the three suffixes, resulting in 6 hours as the average burden. This estimate is an annualized figure based on the average number of responses per respondent and the average burden per response over a 3- year period. We understand that there is a certain amount of research and other costs that an applicant might encounter in analyzing any proposed name for a biological product. We also recognize that the burden may be higher for some applicants and lower for other applicants based on a variety of factors specific to the applicant. The comment suggesting that it will take 720 hours to complete an analysis [[Page 35368]] and submission for each suffix does not provide a basis by which the estimate was calculated or whether it is broadly applicable. We find this figure rather high and retain our original estimate of 6 hours. The latter figure is based on our familiarity with the average amount of time required by similar submissions to FDA. At the same time, the comment also suggested that we failed to adequately account for the time spent on creating proposed suffixes. In consideration, therefore, we have revised our estimate upward to account for burden associated with creating and submitting up to 10 proposed suffixes for designation, as reflected in table 1. FDA estimates the information collection burden as follows: Description of Respondents: Respondents to the collection are sponsors of biological product applications. Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Information for the Proposed 20 2 40 420 16,800 Proper Name for Biological Products Submitted Under Section 351(a) of the PHS Act.. Information for the Proposed 3 2 6 420 2,520 Proper Name for Biosimilar Products and Interchangeable Products Submitted Under Section 351(k) of the PHS Act.. ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 19,320 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information for the submission of a biologics license application (BLA) and changes (supplements) to an approved application under 21 CFR part 601 have been approved under OMB control number 0910-0338. The collections of information for the submission of a BLA under section 351(k) of the PHS Act (biosimilar products and interchangeable products) have been approved under OMB control number 0910-0719. Dated: May 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-12885 Filed 6-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices 35367
Medicine (IOM) Report,’’ Washington DC: Biological Products.’’ Also include the submitted under section 351(k) of the
The National Academies Press (2013). FDA docket number found in brackets PHS Act. The average burden per
3. Strom, B. L., C. A. M. Anderson, and J. in the heading of this document. response (hours) is based on our
H. Ix. ‘‘Sodium Reduction in Populations: experience with similar information
Insights From the Institute of Medicine FOR FURTHER INFORMATION CONTACT: FDA
Committee.’’ Journal of the American PRA Staff, Office of Operations, Food collection requirements for applicants to
Medical Association. July 3, 2013; 310(1): 31– and Drug Administration, 8455 create and submit suffix proposals to
32. Colesville Rd., COLE–14526, Silver FDA and in consideration of comments
4. ‘‘Scientific Report of the 2015 Dietary Spring, MD 20993–0002, PRAStaff@ received in response to our 60-day
Guidelines Advisory Committee,’’ Part B, fda.hhs.gov. notice.
Chapter 6. http://www.health.gov/ In the Federal Register of August 28,
dietaryguidelines/2015-scientific-report/. SUPPLEMENTARY INFORMATION: In 2015 (80 FR 52296), we published a 60-
Accessed March 9, 2015. compliance with 44 U.S.C. 3507, FDA day notice requesting public comment
5. Coxson, P. G., N. R. Cook, M. Joffres, Y. has submitted the following proposed on the proposed collection of
Hong, et al. ‘‘Mortality Benefits From U.S. collection of information to OMB for information. Most comments supported
Population-Wide Reduction in Sodium review and clearance. our proposal to designate a suffix. Many
Consumption.’’ Hypertension. March 2013;
61:564–570. Guidance for Industry on comments suggested that a meaningful,
6. Mattes, R. D. and D. Donnelly. ‘‘Relative Nonproprietary Naming of Biological distinguishable suffix may help to
Constitutions of Dietary Sodium Sources.’’ Products OMB Control Number 0910– improve pharmacovigilance, enhance
Journal of the American College of Nutrition. NEW safety, and facilitate identification
August 1991;10(4):383–93. between biological products. Some
7. FDA. ‘‘Memo: Target Development The guidance entitled ‘‘Guidance for comments supported use of a random
Example: Supplementary Memorandum to Industry on Nonproprietary Naming of suffix to avoid creating an unfair
the Draft Guidance (2016).’’ Biological Products’’ describes FDA’s advantage for specific manufacturers.
current thinking on the need for Several comments stated that the
Dated: May 27, 2016.
biological products licensed under the current practices of FDA and non-FDA
Leslie Kux,
Public Health Service Act (PHS Act) to entities for identifying biosimilar and
Associate Commissioner for Policy. bear a nonproprietary name that
[FR Doc. 2016–12950 Filed 6–1–16; 8:45 am]
interchangeable products is sufficient
includes an FDA-designated suffix. for the purpose of pharmacovigilance,
BILLING CODE 4164–01–P There is a need to clearly identify and designation of a suffix is not
biological products to facilitate needed. One comment stated that FDA’s
pharmacovigilance and, for the estimate of 6 hours to submit proposed
DEPARTMENT OF HEALTH AND purposes of safe use, to minimize
HUMAN SERVICES suffixes is based only on the time
inadvertent substitution. Accordingly, needed to prepare the submission itself
for biological products licensed under after the multiple suffixes have been
Food and Drug Administration
the PHS Act, FDA intends to designate selected. The comment further stated
[Docket No. FDA–2013–D–1543] a nonproprietary name that includes a that because FDA suggests that each
core name and a distinguishing suffix. respondent submit three suggested
Agency Information Collection This naming convention is applicable to suffixes for consideration, the time
Activities; Submission for Office of biological products previously licensed needed to do an analysis of each suffix
Management and Budget Review; and newly licensed under section 351(a) would exceed 720 hours per suffix
Comment Request; Guidance for or 351(k) of the PHS Act (42 U.S.C. (based on their own company
Industry on Nonproprietary Naming of 262(a) or 262(k)). experience) or 2,160 hours total for the
Biological Products The guidance includes information three suffixes.
AGENCY: Food and Drug Administration, collection by requesting that applicants In response to the comments we note
HHS. propose a suffix composed of four that our estimated annual reporting
lowercase letters for use as the burden results from information that
ACTION: Notice. distinguishing identifier included in the would be submitted to us by applicants
SUMMARY: The Food and Drug proper name designated by FDA at the in order to facilitate Agency designation
Administration (FDA) is announcing time of licensure for biological products of a suffix as part of the proper name of
that a proposed collection of licensed under the PHS Act. The suffix a biological product. We estimated that
information has been submitted to the will be incorporated in the sponsors would spend 2 hours
Office of Management and Budget nonproprietary name of the product. completing the submission for each of
(OMB) for review and clearance under The guidance recommends that the three suffixes, resulting in 6 hours
the Paperwork Reduction Act of 1995. applicants should submit up to 10 as the average burden. This estimate is
proposed suffixes, in the order of the an annualized figure based on the
DATES: Fax written comments on the
applicant’s preference. We also average number of responses per
collection of information by July 5,
recommend including supporting respondent and the average burden per
2016.
analyses demonstrating that the response over a 3-year period. We
ADDRESSES: To ensure that comments on proposed suffixes meet the factors understand that there is a certain
the information collection are received, described in the guidance for FDA’s amount of research and other costs that
OMB recommends that written consideration. an applicant might encounter in
asabaliauskas on DSK3SPTVN1PROD with NOTICES
comments be faxed to the Office of As indicated in table 1, we estimate analyzing any proposed name for a
Information and Regulatory Affairs, that we will receive a total of 40 biological product. We also recognize
OMB, Attn: FDA Desk Officer, FAX: requests annually for the proposed that the burden may be higher for some
202–395–7285, or emailed to oira_ proper name for biological products applicants and lower for other
submission@omb.eop.gov. All submitted under section 351(a) of the applicants based on a variety of factors
comments should be identified with the PHS Act, and 6 requests annually for the specific to the applicant.
OMB control number 0910–NEW and proposed proper name for biosimilar The comment suggesting that it will
title ‘‘Nonproprietary Naming of products and interchangeable products take 720 hours to complete an analysis
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![35368 Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices
and submission for each suffix does not FDA. At the same time, the comment submitting up to 10 proposed suffixes
provide a basis by which the estimate also suggested that we failed to for designation, as reflected in table 1.
was calculated or whether it is broadly adequately account for the time spent FDA estimates the information
applicable. We find this figure rather on creating proposed suffixes. In collection burden as follows:
high and retain our original estimate of consideration, therefore, we have Description of Respondents:
6 hours. The latter figure is based on our revised our estimate upward to account Respondents to the collection are
familiarity with the average amount of for burden associated with creating and sponsors of biological product
time required by similar submissions to applications.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Information for the Proposed Proper Name for Biological
Products Submitted Under Section 351(a) of the PHS
Act .................................................................................... 20 2 40 420 16,800
Information for the Proposed Proper Name for Biosimilar
Products and Interchangeable Products Submitted
Under Section 351(k) of the PHS Act .............................. 3 2 6 420 2,520
Total .............................................................................. ........................ ........................ ........................ ........................ 19,320
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The guidance also refers to previously Services Administration, Conference FOR FURTHER INFORMATION CONTACT:
approved collections of information Room #5E29, 5600 Fishers Lane, Please send requests for information to
found in FDA regulations. The Rockville, Maryland 20857, Webinar Dawn Smith, Bureau of Health
collections of information for the and Conference Call Format. Workforce, HRSA, in one of two ways:
submission of a biologics license Status: This advisory council meeting (1) Send a request to the following
application (BLA) and changes will be open to the public. address: Dawn Smith, Bureau of Health
(supplements) to an approved Workforce, Health Resources and
Purpose: The NACNHSC provides
application under 21 CFR part 601 have Services Administration, Room 14N70B,
advice and recommendations to the 5600 Fishers Lane, Rockville, Maryland
been approved under OMB control
Secretary of the U.S. Department of 20857; or (2) send an email to dsmith3@
number 0910–0338. The collections of
Health and Human Services (HHS) and, hrsa.gov.
information for the submission of a BLA
by designation, the Administrator of the
under section 351(k) of the PHS Act SUPPLEMENTARY INFORMATION: Further
Health Resources and Services
(biosimilar products and information regarding the NACNHSC,
Administration (HRSA) on a range of
interchangeable products) have been including the roster of members and
issues including identifying the
approved under OMB control number past meeting summaries, is available at:
priorities for the National Health
0910–0719. http://nhsc.hrsa.gov/corpsexperience/
Service Corps (NHSC) and policy
Dated: May 26, 2016. aboutus/nationaladvisorycouncil/
revisions.
Leslie Kux,
meetingsummaries/index.html.
Agenda: The NACNHSC will refine Members of the public and interested
Associate Commissioner for Policy. the Council’s top priorities for the parties may request to participate in the
[FR Doc. 2016–12885 Filed 6–1–16; 8:45 am] NHSC and will continue to work on the meeting by contacting Dawn Smith via
BILLING CODE 4164–01–P draft of formal recommendations to email at dsmith3@hrsa.gov to obtain
submit to the HHS Secretary and the access information. Access will be
HRSA Administrator. During the March granted on a first come, first served
DEPARTMENT OF HEALTH AND 2016 NACNHSC meeting, the Council basis. Individuals who plan to attend
HUMAN SERVICES identified its priorities for the NHSC. and need special assistance, such as
The Council will continue the sign language interpretation or other
Health Resources and Services discussion on how the priorities meet reasonable accommodations, should
Administration the goals of the 2016 Bureau of Health notify the contact person listed above at
National Advisory Council on the Workforce Strategic Plan. The priority least 10 days prior to the meeting.
National Health Service Corps; Notice areas include, but are not limited to, Public participants may submit written
of Meeting telehealth, Medication Assisted statements in advance of the scheduled
Treatment (MAT) certification, meeting. If you would like to provide
In accordance with section 10(a)(2) of mentorship and NHSC discipline oral public comment during the
the Federal Advisory Committee Act expansion, specifically for mental and meeting, please register with Dawn
(Pub. L. 92–463), notice is hereby given behavioral and oral health providers. Smith. Public comment will be limited
asabaliauskas on DSK3SPTVN1PROD with NOTICES
of the following meeting: The content of the agenda is subject to to 3 minutes per speaker. Statements
Name: National Advisory Council on change prior to the meeting. The and comments can be addressed to
the National Health Service Corps NACNHSC final agenda and call-in Dawn Smith by emailing her at dsmith@
(NACNHSC). information will be available 3 days in hrsa.gov.
Dates and Times: June 22, 2016 11:00 advance of the meeting at http:// In addition, please be advised that
a.m.–5:00 p.m. EST. nhsc.hrsa.gov/corpsexperience/aboutus/ committee members are given copies of
Place: U.S. Department of Health and nationaladvisorycouncil/ all written statements submitted from
Human Services, Health Resources and meetingsummaries/index.html. the public. Any further public
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Document Created: 2016-06-02 01:23:18
Document Modified: 2016-06-02 01:23:18
| 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 July 5, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 35367 |
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