83 FR 42130 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 161 (August 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 161 (August 20, 2018)
| Page Range | 42130-42131 | |
| FR Document | 2018-17859 |
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)] [Notices] [Pages 42130-42131] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17859] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3038] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 September 19, 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 0910-0206. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Request for Samples and Protocols OMB Control Number 0910-0206--Extension This information collection supports Agency regulations. 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); and 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 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 [[Page 42131]] 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 2 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. In the Federal Register of May 11, 2018, (83 FR 22081), we published a notice soliciting public comment of the information collection. No comments were received. We therefore estimate the burden of the information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section/activity Number of responses per Total annual Average burden Total hours respondents respondent responses per 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....................... .............. .............. .............. .............. 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: August 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17859 Filed 8-17-18; 8:45 am] BILLING CODE 4164-01-P
![42130 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
The burden for this information Request for Samples and Protocols or absent to be submitted to the CBER
collection has changed since the last Director at the time of initial
OMB Control Number 0910–0206—
OMB approval. Our burden estimate distribution of each lot.
Extension Section 660.46(a) contains
reflects a decrease in burden by 14
records and 112 hours. We attribute this This information collection supports requirements as to the frequency of
adjustment to a decrease in the number Agency regulations. Under section 351 submission of samples from each lot of
of requests received over the last few of the Public Health Service Act (42 Hepatitis B Surface Antigen product,
years. U.S.C. 262), FDA has the responsibility and § 660.46(b) contains the
to issue regulations that prescribe requirements as to the submission of a
Dated: August 14, 2018.
standards designed to ensure the safety, protocol containing specific information
Leslie Kux, purity, and potency of biological along with each required sample. For
Associate Commissioner for Policy. products and to ensure that the § 660.46 products subject to official
[FR Doc. 2018–17860 Filed 8–17–18; 8:45 am] biologics licenses for such products are release by CBER, one sample from each
BILLING CODE 4164–01–P only issued when a product meets the filling of each lot is required to be
prescribed standards. Under § 610.2 (21 submitted along with a protocol
CFR 610.2), the Center for Biologics consisting of a summary of the history
DEPARTMENT OF HEALTH AND Evaluation and Research (CBER) or the or manufacture of the product,
HUMAN SERVICES Center for Drug Evaluation and Research including all results of each test for
may at any time require manufacturers which test results are requested by
Food and Drug Administration of licensed biological products to CBER. After notification of official
submit to FDA samples of any lot along release is received, one sample along
[Docket No. FDA–2018–N–3038] with the protocols showing the results with a protocol is required to be
of applicable tests prior to distributing submitted at 90-day intervals. In
Agency Information Collection the lot of the product. In addition to addition, samples, which must be
Activities; Submission for Office of § 610.2, there are other regulations that accompanied by a protocol, may at any
Management and Budget Review; require the submission of samples and time be required to be submitted to
Comment Request; Request for protocols for specific licensed biological CBER if continued evaluation is deemed
Samples and Protocols products: 21 CFR 660.6 (Antibody to necessary.
AGENCY: Food and Drug Administration, Hepatitis B Surface Antigen); 21 CFR Samples and protocols are required by
660.36 (Reagent Red Blood Cells); and FDA to help ensure the safety, purity, or
HHS.
21 CFR 660.46 (Hepatitis B Surface potency of the product because of the
ACTION: Notice. Antigen). potential lot-to-lot variability of a
Section 660.6(a) provides product produced from living
SUMMARY: The Food and Drug
requirements for the frequency of organisms. In cases of certain biological
Administration (FDA, Agency, or we) is
submission of samples from each lot of products (e.g., Albumin, Plasma Protein
announcing that a proposed collection Antibody to Hepatitis B Surface Antigen Fraction, and therapeutic biological
of information has been submitted to the product, and § 660.6(b) provides the products) that are known to have lot-to-
Office of Management and Budget requirements for the submission of a lot consistency, official lot release is not
(OMB) for review and clearance under protocol containing specific information normally required. However,
the Paperwork Reduction Act of 1995. along with each required sample. For submissions of samples and protocols of
DATES: Fax written comments on the § 660.6 products subject to official these products may still be required for
collection of information by September release by CBER, one sample from each surveillance, licensing, and export
19, 2018. filling of each lot is required to be purposes, or in the event that FDA
ADDRESSES: To ensure that comments on submitted along with a protocol obtains information that the
the information collection are received, consisting of a summary of the history manufacturing process may not result in
OMB recommends that written of manufacture of the product, consistent quality of the product.
comments be faxed to the Office of including all results of each test for The following burden estimate is for
Information and Regulatory Affairs, which test results are requested by the protocols required to be submitted
OMB, Attn: FDA Desk Officer, Fax: 202– CBER. After official release is no longer with each sample. The collection of
395–7285, or emailed to oira_ required, one sample along with a samples is not a collection of
submission@omb.eop.gov. All protocol is required to be submitted at information under 5 CFR 1320.3(h)(2).
comments should be identified with the 90-day intervals. In addition, samples, Respondents to the collection of
OMB control number 0910–0206. Also which must be accompanied by a information under § 610.2 are
include the FDA docket number found protocol, may at any time be required to manufacturers of licensed biological
in brackets in the heading of this be submitted to CBER if continued products. Respondents to the collection
document. evaluation is deemed necessary. of information under §§ 660.6(b),
Section 660.36(a) requires, after each 660.36(a)(2) and (b), and 660.46(b) are
FOR FURTHER INFORMATION CONTACT: Ila routine establishment inspection by manufacturers of the specific products
Mizrachi, Office of Operations, Food FDA, the submission of samples from a referenced previously in this document.
and Drug Administration, Three White lot of final Reagent Red Blood Cell The estimated number of respondents
Flint North, 10A–12M, 11601 product along with a protocol for each regulation is based on the
Landsdown St., North Bethesda, MD containing specific information. Section annual number of manufacturers that
daltland on DSKBBV9HB2PROD with NOTICES
20852, 301–796–7726, PRAStaff@ 660.36(a)(2) requires that a protocol submitted samples and protocols for
fda.hhs.gov. contain information including, but not biological products including
SUPPLEMENTARY INFORMATION: In limited to, manufacturing records, submissions for lot release, surveillance,
compliance with 44 U.S.C. 3507, FDA certain test records, and identity test licensing, or export. Based on
has submitted the following proposed results. Section 660.36(b) requires a information obtained from FDA’s
collection of information to OMB for copy of the antigenic constitution database system, approximately 79
review and clearance. matrix specifying the antigens present manufacturers submitted samples and
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![Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42131
protocols in fiscal year (FY) 2017, under The estimated total annual responses regulations, the average burden per
the regulations cited previously in this are based on FDA’s final actions response is based on the higher end of
document. FDA estimates that completed in FY 2017 for the various the estimate (rounded to 5 or 6 hours)
approximately 75 manufacturers submission requirements of samples since more information is generally
submitted protocols under § 610.2 and 2 and protocols for the licensed biological required to be submitted in the other
manufacturers submitted protocols products. The average burden per protocols than under § 610.2.
under the regulation (§ 660.6) for the response is based on information In the Federal Register of May 11,
other specific product. FDA received no provided by industry. The burden 2018, (83 FR 22081), we published a
submissions under §§ 660.36 or 660.46; estimates provided by industry ranged notice soliciting public comment of the
however, FDA is using the estimate of from 1 to 5.5 hours. Under § 610.2, the information collection. No comments
one protocol submission under each hours per response are based on the were received.
regulation in the event that protocols are average of these estimates and rounded We therefore estimate the burden of
submitted in the future. to 3 hours. Under the remaining the information 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 .............................................................................. ........................ ........................ ........................ ........................ 19,456
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the and Human Services, is publishing the techniques or other forms of information
information collection reflects an following summary of a proposed technology to minimize the information
overall increase of 764 hours and a collection for public comment. collection burden.
corresponding increase of 262 DATES: Comments on the ICR must be Title of the Collection: Office of
responses. We attribute this adjustment received on or before September 19, Adolescent Health Teen Pregnancy
to an increase in the number of 2018. Prevention, FY 2015–2020 Performance
submissions we received over the last Measure Collection.
few years. ADDRESSES: Submit your comments to
Type of Collection: Extension.
OIRA_submission@omb.eop.gov or via
Dated: August 14, 2018. OMB No. 0990–0438.
facsimile to (202) 395–5806.
Leslie Kux, Abstract: The Office of Adolescent
FOR FURTHER INFORMATION CONTACT:
Associate Commissioner for Policy. Health (OAH), U.S. Department of
Sherrette Funn, Sherrette.Funn@hhs.gov Health and Human Services (HHS), is
[FR Doc. 2018–17859 Filed 8–17–18; 8:45 am] or (202) 795–7714. When submitting requesting renewal by OMB of the
BILLING CODE 4164–01–P comments or requesting information, existing information collection request
please include the document identifier for performance measures collection
0990–New–30D and project title for from the TPP grant recipients.
DEPARTMENT OF HEALTH AND reference.
HUMAN SERVICES Performance measure data collection is
SUPPLEMENTARY INFORMATION: Interested a requirement of TPP grants; the
[Document Identifier: OS–0990–0438] persons are invited to send comments extension will allow for the completion
regarding this burden estimate or any of data collection from cohort 2. The
Agency Information Collection other aspect of this collection of collection will provide OAH with
Request; 30-Day Public Comment information, including any of the performance data to inform planning
Request following subjects: (1) The necessity and decisions; identify technical assistance
AGENCY: Office of the Secretary, HHS utility of the proposed information needs for grantees; facilitate grantees’
ACTION: Notice. collection for the proper performance of continuous quality improvement in
the agency’s functions; (2) the accuracy program implementation; and provide
SUMMARY: In compliance with the of the estimated burden; (3) ways to HHS, Congress, OMB, and the general
requirement of the Paperwork enhance the quality, utility, and clarity public with information about the
Reduction Act of 1995, the Office of the of the information to be collected; and individuals who participate in TPP-
Secretary (OS), Department of Health (4) the use of automated collection funded activities.
ESTIMATED ANNUALIZED BURDEN TABLE
daltland on DSKBBV9HB2PROD with NOTICES
Average
Number of
Number of burden Total burden
Type of respondent responses per
respondents per response hours
respondent (in hours)
Grant Recipient—Dissemination Form ...................................................... 84 2 15/60 42
Grant Recipient—Partnerships Form ........................................................ 84 2 15/60 42
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Document Created: 2018-08-18 01:29:09
Document Modified: 2018-08-18 01:29:09
| 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 September 19, 2018. | |
| Contact | Ila 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 42130 |
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