83 FR 22081 - Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 92 (May 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 92 (May 11, 2018)
| Page Range | 22081-22083 | |
| FR Document | 2018-10052 |
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)] [Notices] [Pages 22081-22083] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10052] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1565] Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the Agency. DATES: Submit either electronic or written comments on the collection of information by July 10, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 10, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-2018-N-1565 for ``Request for Samples [[Page 22082]] and Protocols.'' Received comments, those filed in a timely manner (see ADDRESSES), 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Request for Samples and Protocols OMB Control Number 0910-0206--Extension Under section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has the responsibility to issue regulations that prescribe standards designed to ensure the safety, purity, and potency of biological products and to ensure that the biologics licenses for such products are only issued when a product meets the prescribed standards. Under Sec. 610.2 (21 CFR 610.2), the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot along with the protocols showing the results of applicable tests prior to distributing the lot of the product. In addition to Sec. 610.2, there are other regulations that require the submission of samples and protocols for specific licensed biological products: 21 CFR 660.6 (Antibody to Hepatitis B Surface Antigen); 21 CFR 660.36 (Reagent Red Blood Cells); 21 CFR 660.46) (Hepatitis B Surface Antigen). Section 660.6(a) provides requirements for the frequency of submission of samples from each lot of Antibody to Hepatitis B Surface Antigen product, and Sec. 660.6(b) provides the requirements for the submission of a protocol containing specific information along with each required sample. For Sec. 660.6 products subject to official release by CBER, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history of manufacture of the product, including all results of each test for which test results are requested by CBER. After official release is no longer required, one sample along with a protocol is required to be submitted at 90-day intervals. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to CBER if continued evaluation is deemed necessary. Section 660.36(a) requires, after each routine establishment inspection by FDA, the submission of samples from a lot of final Reagent Red Blood Cell product along with a protocol containing specific information. Section 660.36(a)(2) requires that a protocol contain information including, but not limited to, manufacturing records, certain test records, and identity test results. Section 660.36(b) requires a copy of the antigenic constitution matrix specifying the antigens present or absent to be submitted to the CBER Director at the time of initial distribution of each lot. Section 660.46(a) contains requirements as to the frequency of submission of samples from each lot of Hepatitis B Surface Antigen product, and Sec. 660.46(b) contains the requirements as to the submission of a protocol containing specific information along with each required sample. For Sec. 660.46 products subject to official release by CBER, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history or manufacture of the product, including all results of each test for which test results are requested by CBER. After notification of official release is received, one sample along with a protocol is required to be submitted at 90-day intervals. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to CBER if continued evaluation is deemed necessary. Samples and protocols are required by FDA to help ensure the safety, purity, or potency of the product because of the potential lot- to-lot variability of a [[Page 22083]] product produced from living organisms. In cases of certain biological products (e.g., Albumin, Plasma Protein Fraction, and therapeutic biological products) that are known to have lot-to-lot consistency, official lot release is not normally required. However, submissions of samples and protocols of these products may still be required for surveillance, licensing, and export purposes, or in the event that FDA obtains information that the manufacturing process may not result in consistent quality of the product. The following burden estimate is for the protocols required to be submitted with each sample. The collection of samples is not a collection of information under 5 CFR 1320.3(h)(2). Respondents to the collection of information under Sec. 610.2 are manufacturers of licensed biological products. Respondents to the collection of information under Sec. Sec. 660.6(b), 660.36(a)(2) and (b), and 660.46(b) are manufacturers of the specific products referenced previously in this document. The estimated number of respondents for each regulation is based on the annual number of manufacturers that submitted samples and protocols for biological products including submissions for lot release, surveillance, licensing, or export. Based on information obtained from FDA's database system, approximately 79 manufacturers submitted samples and protocols in fiscal year (FY) 2017, under the regulations cited previously in this document. FDA estimates that approximately 75 manufacturers submitted protocols under Sec. 610.2 and two manufacturers submitted protocols under the regulation (Sec. 660.6) for the other specific product. FDA received no submissions under Sec. Sec. 660.36 or 660.46, however FDA is using the estimate of one protocol submission under each regulation in the event that protocols are submitted in the future. The estimated total annual responses are based on FDA's final actions completed in FY 2017 for the various submission requirements of samples and protocols for the licensed biological products. The average burden per response is based on information provided by industry. The burden estimates provided by industry ranged from 1 to 5.5 hours. Under Sec. 610.2, the hours per response are based on the average of these estimates and rounded to 3 hours. Under the remaining regulations, the average burden per response is based on the higher end of the estimate (rounded to 5 or 6 hours) since more information is generally required to be submitted in the other protocols than under Sec. 610.2. FDA estimates the burden of this information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section/activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 610.2--Requests for Samples and 75 86.267 6,470 3 19,410 Protocols; Official Release.... 660.6(b)--Protocols............. 2 3.5 7 5 35 660.36(a)(2) and (b)--Samples 1 1 1 6 6 and Protocols.................. 660.46(b)--Protocols............ 1 1 1 5 5 ------------------------------------------------------------------------------- Total....................... 79 .............. 6,479 .............. 19,456 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall increase of 764 hours and a corresponding increase of 262 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Dated: May 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10052 Filed 5-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices 22081
information line to learn about possible hearing session. The contact person will DATES: Submit either electronic or
modifications before coming to the notify interested persons regarding their written comments on the collection of
meeting. request to speak by May 29, 2018. information by July 10, 2018.
SUPPLEMENTARY INFORMATION: Persons attending FDA’s advisory ADDRESSES: You may submit comments
Agenda: On June 12, 2018, the committee meetings are advised that the as follows. Please note that late,
committee will discuss, make Agency is not responsible for providing untimely filed comments will not be
recommendations, and vote on the access to electrical outlets. considered. Electronic comments must
premarket approval application FDA welcomes the attendance of the be submitted on or before July 10, 2018.
sponsored by Cordis, Inc. for the public at its advisory committee The https://www.regulations.gov
INCRAFT AAA Stent Graft System, meetings and will make every effort to electronic filing system will accept
which is intended for the endovascular accommodate persons with disabilities. comments until midnight Eastern Time
treatment of infra-renal abdominal If you require accommodations due to a at the end of July 10, 2018. Comments
aortic aneurysms in patients with disability, please contact AnnMarie received by mail/hand delivery/courier
appropriate anatomy. The INCRAFT Williams at Annmarie.Williams@ (for written/paper submissions) will be
device is being evaluated in the fda.hhs.gov, 301–796–5966 at least 7 considered timely if they are
INSPIRATION study, a multicenter, days in advance of the meeting. postmarked or the delivery service
prospective, non-randomized FDA is committed to the orderly acceptance receipt is on or before that
investigation. The study met its primary conduct of its advisory committee date.
safety and effectiveness endpoints, but meetings. Please visit our website at
Electronic Submissions
results also showed higher than https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/ Submit electronic comments in the
anticipated rates of certain adverse
ucm111462.htm for procedures on following way:
events. The committee discussion will • Federal eRulemaking Portal:
focus on how these events impact the public conduct during advisory
committee meetings. https://www.regulations.gov. Follow the
long-term safety and effectiveness, as instructions for submitting comments.
well as the benefit/risk profile of the Notice of this meeting is given under
the Federal Advisory Committee Act (5 Comments submitted electronically,
device. including attachments, to https://
FDA intends to make background U.S.C. app. 2).
www.regulations.gov will be posted to
material available to the public no later Dated: May 7, 2018.
the docket unchanged. Because your
than 2 business days before the meeting. Leslie Kux, comment will be made public, you are
If FDA is unable to post the background Associate Commissioner for Policy. solely responsible for ensuring that your
material on its website prior to the [FR Doc. 2018–10050 Filed 5–10–18; 8:45 am] comment does not include any
meeting, the background material will
BILLING CODE 4164–01–P confidential information that you or a
be made publicly available at the
third party may not wish to be posted,
location of the advisory committee
such as medical information, your or
meeting, and the background material DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
will be posted on FDA’s website after HUMAN SERVICES confidential business information, such
the meeting. Background material is
as a manufacturing process. Please note
available at https://www.fda.gov/ Food and Drug Administration that if you include your name, contact
AdvisoryCommittees/Calendar/
[Docket No. FDA–2018–N–1565] information, or other information that
default.htm. Scroll down to the
identifies you in the body of your
appropriate advisory committee meeting Agency Information Collection comments, that information will be
link. Activities; Proposed Collection; posted on https://www.regulations.gov.
Procedure: Interested persons may • If you want to submit a comment
Comment Request; Request for
present data, information, or views, with confidential information that you
Samples and Protocols
orally or in writing, on issues pending do not wish to be made available to the
before the committee. Written AGENCY: Food and Drug Administration, public, submit the comment as a
submissions may be made to the contact HHS. written/paper submission and in the
person on or before June 5, 2018. Oral ACTION: Notice. manner detailed (see ‘‘Written/Paper
presentations from the public will be Submissions’’ and ‘‘Instructions’’).
scheduled on June 12, 2018, between SUMMARY: The Food and Drug
approximately 1 p.m. and 2 p.m. Those Administration (FDA or Agency) is Written/Paper Submissions
individuals interested in making formal announcing an opportunity for public Submit written/paper submissions as
oral presentations should notify the comment on the proposed collection of follows:
contact person and submit a brief certain information by the Agency. • Mail/Hand delivery/Courier (for
statement of the general nature of the Under the Paperwork Reduction Act of written/paper submissions): Dockets
evidence or arguments they wish to 1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and
present, the names and addresses of required to publish notice in the Drug Administration, 5630 Fishers
proposed participants, and an Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852.
indication of the approximate time proposed collection of information, • For written/paper comments
requested to make their presentation on including each proposed extension of an submitted to the Dockets Management
or before May 25, 2018. Time allotted existing collection of information, and
sradovich on DSK3GMQ082PROD with NOTICES
Staff, FDA will post your comment, as
for each presentation may be limited. If to allow 60 days for public comment in well as any attachments, except for
the number of registrants requesting to response to the notice. This notice information submitted, marked and
speak is greater than can be reasonably solicits comments on the information identified, as confidential, if submitted
accommodated during the scheduled collection requirements relating to the as detailed in ‘‘Instructions.’’
open public hearing session, FDA may regulations which state that protocols Instructions: All submissions received
conduct a lottery to determine the for samples of biological products must must include the Docket No. FDA–
speakers for the scheduled open public be submitted to the Agency. 2018–N–1565 for ‘‘Request for Samples
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![Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices 22083
product produced from living 660.36(a)(2) and (b), and 660.46(b) are regulation in the event that protocols are
organisms. In cases of certain biological manufacturers of the specific products submitted in the future.
products (e.g., Albumin, Plasma Protein referenced previously in this document. The estimated total annual responses
Fraction, and therapeutic biological The estimated number of respondents are based on FDA’s final actions
products) that are known to have lot-to- for each regulation is based on the completed in FY 2017 for the various
lot consistency, official lot release is not annual number of manufacturers that
submission requirements of samples
normally required. However, submitted samples and protocols for
and protocols for the licensed biological
submissions of samples and protocols of biological products including
these products may still be required for submissions for lot release, surveillance, products. The average burden per
surveillance, licensing, and export licensing, or export. Based on response is based on information
purposes, or in the event that FDA information obtained from FDA’s provided by industry. The burden
obtains information that the database system, approximately 79 estimates provided by industry ranged
manufacturing process may not result in manufacturers submitted samples and from 1 to 5.5 hours. Under § 610.2, the
consistent quality of the product. protocols in fiscal year (FY) 2017, under hours per response are based on the
The following burden estimate is for the regulations cited previously in this average of these estimates and rounded
the protocols required to be submitted document. FDA estimates that to 3 hours. Under the remaining
with each sample. The collection of approximately 75 manufacturers regulations, the average burden per
samples is not a collection of submitted protocols under § 610.2 and response is based on the higher end of
information under 5 CFR 1320.3(h)(2). two manufacturers submitted protocols the estimate (rounded to 5 or 6 hours)
Respondents to the collection of under the regulation (§ 660.6) for the since more information is generally
information under § 610.2 are other specific product. FDA received no required to be submitted in the other
manufacturers of licensed biological submissions under §§ 660.36 or 660.46, protocols than under § 610.2. FDA
products. Respondents to the collection however FDA is using the estimate of estimates the burden of this information
of information under §§ 660.6(b), one protocol submission under each collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section/activity responses per burden per Total hours
respondents responses
respondent response
610.2—Requests for Samples and Protocols; Official Re-
lease ................................................................................. 75 86.267 6,470 3 19,410
660.6(b)—Protocols ............................................................. 2 3.5 7 5 35
660.36(a)(2) and (b)—Samples and Protocols .................... 1 1 1 6 6
660.46(b)—Protocols ........................................................... 1 1 1 5 5
Total .............................................................................. 79 ........................ 6,479 ........................ 19,456
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the ACTION: Notice of availability. DATES: The announcement of the
information collection reflects an guidance is published in the Federal
overall increase of 764 hours and a SUMMARY: The Food and Drug Register on May 11, 2018.
corresponding increase of 262 Administration (FDA or Agency) is ADDRESSES: You may submit either
responses. We attribute this adjustment announcing the availability of a final electronic or written comments on
to an increase in the number of guidance for industry entitled ‘‘Facility Agency guidances at any time as
submissions we received over the last Definition Under Section 503B of the follows:
few years. Federal Food, Drug, and Cosmetic Act.’’ Electronic Submissions
Dated: May 7, 2018. Section 503B defines an outsourcing
facility, in part, as ‘‘a facility at one Submit electronic comments in the
Leslie Kux,
following way:
Associate Commissioner for Policy. geographic location or address.’’ FDA
• Federal eRulemaking Portal.
[FR Doc. 2018–10052 Filed 5–10–18; 8:45 am] has received questions from outsourcing https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P facilities and other stakeholders about instructions for submitting comments.
the meaning of this term, such as Comments submitted electronically,
whether multiple suites used for including attachments, to https://
DEPARTMENT OF HEALTH AND compounding human drugs at a single www.regulations.gov will be posted to
HUMAN SERVICES street address constitute one or multiple the docket unchanged. Because your
facilities, or whether a single location comment will be made public, you are
Food and Drug Administration where human drugs are compounded solely responsible for ensuring that your
can be subdivided into separate comment does not include any
[Docket No. FDA–2016–D–0238] operations compounding under confidential information that you or a
sradovich on DSK3GMQ082PROD with NOTICES
different standards. FDA is issuing this third party may not wish to be posted,
Facility Definition Under Section 503B
guidance to provide the Agency’s such as medical information, your or
of the Federal Food, Drug, and
current thinking on these questions and anyone else’s Social Security number, or
Cosmetic Act; Guidance for Industry;
related issues regarding how to ensure confidential business information, such
Availability
that the compounding of drugs in an as a manufacturing process. Please note
AGENCY: Food and Drug Administration, outsourcing facility occurs only in that if you include your name, contact
HHS. accordance with section 503B. information, or other information that
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Document Created: 2018-11-02 09:50:20
Document Modified: 2018-11-02 09:50:20
| 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 | Submit either electronic or written comments on the collection of information by July 10, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 22081 |
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