83 FR 819 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Adverse Experience Reporting for Licensed Biological Products; and General Records
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 5 (January 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 5 (January 8, 2018)
| Page Range | 819-821 | |
| FR Document | 2018-00095 |
[Federal Register Volume 83, Number 5 (Monday, January 8, 2018)] [Notices] [Pages 819-821] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00095] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0231] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Adverse Experience Reporting for Licensed Biological Products; and General Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA 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 February 7, 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, [[Page 820]] OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0308. Also include the FDA docket number found in brackets in the heading of this document. 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, PRAStaff@fda.hhs.gov. 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. Adverse Experience Reporting For Licensed Biological Products; and General Records--21 CFR Part 600; OMB Control Number 0910-0308-- Extension Under the Public Health Service Act (42 U.S.C. 262), FDA may only approve a biologics license application for a biological product that is safe, pure, and potent. When a biological product is approved and enters the market, the product is introduced to a larger patient population in settings different from clinical trials. New information generated during the postmarketing period offers further insight into the benefits and risks of the product, and evaluation of this information is important to ensure its safe use. FDA issued the Adverse Experience Reporting (AER) requirements in part 600 (21 CFR part 600) to enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The primary purpose of FDA's AERS is to identify potentially serious safety problems with licensed biological products. Although premarket testing discloses a general safety profile of a biological product's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides the opportunity to collect information on rare, latent, and long-term effects. In addition, production and/or distribution problems have contaminated biological products in the past. AER reports are obtained from a variety of sources, including manufacturers, patients, physicians, foreign regulatory agencies, and clinical investigators. Identification of new and unexpected safety issues through the analysis of the data in AERS contributes directly to increased public health protection. For example, evaluation of these safety issues enables FDA to take focused regulatory action. Such action may include, but is not limited to, important changes to the product's labeling (such as adding a new warning), coordination with manufacturers to ensure adequate corrective action is taken, and removal of a biological product from the market when necessary. Section 600.80(c)(1) requires licensed manufacturers or any person whose name appears on the label of a licensed biological product to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the licensed manufacturer. These reports are known as postmarketing 15-day Alert reports. This section also requires licensed manufacturers to submit any followup reports within 15 calendar days of receipt of new information or as requested by FDA, and if additional information is not obtainable, to maintain records of the unsuccessful steps taken to seek additional information. In addition, this section requires that a person who submits an adverse action report to the licensed manufacturer rather than to FDA, maintain a record of this action. Section 600.80(e) requires licensed manufacturers to submit a 15-day Alert report for an adverse experience obtained from a postmarketing clinical study only if the licensed manufacturer concludes that there is a reasonable possibility that the product caused the adverse experience. Section 600.80(c)(2) requires licensed manufacturers to report each adverse experience not reported in a postmarketing 15-day Alert report at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The majority of these periodic reports are submitted annually, since a large percentage of currently licensed biological products have been licensed longer than 3 years. Section 600.80(k) requires licensed manufacturers to maintain for a period of 10 years records of all adverse experiences known to the licensed manufacturer, including raw data and any correspondence relating to the adverse experiences. Section 600.81 requires licensed manufacturers to submit, at an interval of every 6 months, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. These distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, the fill lot numbers for the total number of dosage units of each strength or potency distributed (e.g., 50,000 per 10-milliliter vials), and date of release. FDA may require the licensed manufacturer to submit distribution reports under this section at times other than every 6 months. Under Sec. 600.82(a), an applicant of a biological product or blood and blood component must notify FDA of a permanent discontinuance of manufacture or an interruption in manufacturing or disruption in supply, as applicable. Under Sec. Sec. 600.80(h)(2) and 600.81(b)(2), a licensed manufacturer may request a temporary waiver for the requirements under Sec. 600.80(h)(1) and (b)(1), respectively. Requests for waivers must be submitted in accordance with Sec. 600.90. Under Sec. 600.90, a licensed manufacturer may submit a waiver request for any requirements that apply to the licensed manufacturer under Sec. Sec. 600.80 and 600.81. A waiver request submitted under Sec. 600.90 must include supporting documentation. Manufacturers of biological products for human use must keep records of each step in the manufacture and distribution of a product, including any recalls. These recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also enable FDA to perform meaningful inspections. Section 600.12 requires, among other things, that records be made concurrently with the performance of each step in the manufacture and distribution of products. These records must be retained for no less than 5 years after the records of manufacture have been completed or 6 months after the latest expiration date for the individual product, whichever represents a later date. In addition, under Sec. 600.12, manufacturers must maintain records relating to the sterilization of equipment and supplies, animal necropsy records, and records in cases of divided manufacturing responsibility with respect to a product. Under Sec. 600.12(b)(2), manufacturers are also required to maintain complete records pertaining to the recall from distribution of any product. Furthermore, Sec. 610.18(b) (21 CFR 610.18(b)) requires, in part, that the results of all periodic tests for verification of cultures and determination of freedom from extraneous organisms be recorded and [[Page 821]] retained. The recordkeeping requirements for Sec. Sec. 610.12(g), 610.13(a)(2), 610.18(d), 21 CFR 680.2(f), and 680.3(f) are approved under OMB control number 0910-0139. Respondents to this collection of information include manufacturers of biological products (including blood and blood components) and any person whose name appears on the label of a licensed biological product. In table 1, the number of respondents is based on the estimated number of manufacturers that are subject to those regulations or that submitted the required information to the Center for Biologics Evaluation and Research and Center for Drugs Evaluation and Research, FDA, in fiscal year (FY) 2016. Based on information obtained from the FDA's database system, there were 93 manufacturers of biological products. This number excludes those manufacturers who produce Whole Blood, components of Whole Blood, or in-vitro diagnostic licensed products, because of the exemption under Sec. 600.80(m). The total annual responses are based on the number of submissions received by FDA in FY 2016. There were an estimated 125,371 15-day Alert reports, 180,580 periodic reports, and 677 lot distribution reports submitted to FDA. The number of 15-day Alert reports for postmarketing studies under Sec. 600.80(e) is included in the total number of 15-day Alert reports. FDA received 81 requests from 40 manufacturers for waivers under Sec. 600.90 (including Sec. Sec. 600.80(h)(2) and 600.81(b)(2)), of which 79 were granted. The hours per response are based on FDA experience. The burden hours required to complete the MedWatch Form (Form FDA 3500A) for Sec. 600.80(c)(1), (e), and (f) are reported under OMB control number 0910-0291. In the Federal Register of July 18, 2017 (82 FR 32836), 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 burden 21 CFR Section Number of responses per Total annual per response (in Total hours respondents respondent responses hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- 600.80(c)(1), 600.80(d), and 600.80(e); postmarketing 15- 93 1,348.07 125,371 1 125,371 day Alert reports....................................... 600.82; notification of discontinuance or interruption in 18 1.61 29 2 58 manufacturing........................................... 600.80(c)(2); periodic adverse experience reports........ 93 1,941.72 180,580 28 5,056,240 600.81 Distribution Reports.............................. 93 7.28 677 1 677 600.80(h)(2), 600.81(b)(2), and 600.90; waiver requests.. 40 2.03 81 1 81 ---------------------------------------------------------------------------------------------- Total................................................ ................. ................. ................. ................. 5,182,427 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. In table 2 the number of respondents is based on the number of manufacturers subject to those regulations. Based on information obtained from FDA's database system, there were 263 licensed manufacturers of biological products in FY 2016. However, the number of recordkeepers listed for Sec. 600.12(a) through (e) excluding (b)(2) is estimated to be 114. This number excludes manufacturers of blood and blood components because their burden hours for recordkeeping have been reported under Sec. 606.160 in OMB control number 0910-0116. The total annual records is based on the annual average of lots released in FY 2016 (7,198), number of recalls made (575), and total number of adverse experience reports received (305,951) in FY 2016. The hours per record are based on FDA experience. FDA estimates the burden of this recordkeeping as follows: Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Average burden Number of Number of Total annual per 21 CFR Section recordkeepers records per records recordkeeper Total hours recordkeeper (in hours) ---------------------------------------------------------------------------------------------------------------- 600.12 \2\; maintenance of 114 63.14 7,198 32 230,336 records........................ 600.12(b)(2); recall records.... 263 2.19 575 24 13,800 600.80(c)(1) and 600.80(k)...... 93 3,289.79 305,951 1 305,951 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 550,087 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ The recordkeeping requirements in Sec. 610.18(b) are included in the estimate for Sec. 600.12. The burden for this information collection has changed since the last OMB approval. Because of an increase in the number of AER reports we have received during the past 3years, we have increased our reporting and recordkeeping burden estimates. Dated: January 2, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00095 Filed 1-5-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices 819
DEPARTMENT OF HEALTH AND proposed collection(s) summarized in individual and small group health
HUMAN SERVICES this notice, you may make your request insurance markets inside and outside of
using one of following: the Health Insurance Exchanges. HHS
Centers for Medicare & Medicaid 1. Access CMS’ website address at will also use this data to adjust the
Services http://www.cms.hhs.gov/Paperwork payment transfer formula for risk
[Document Identifier: CMS–10401] ReductionActof1995. associated with high-cost enrollees.
2. Email your request, including your State regulators can use the reporting
Agency Information Collection address, phone number, OMB number, requirements outlined in this collection
Activities: Proposed Collection; and CMS document identifier, to to request a reduction to the statewide
Comment Request Paperwork@cms.hhs.gov. average premium factor of the risk
3. Call the Reports Clearance Office at adjustment transfer formula, beginning
AGENCY: Centers for Medicare & (410) 786–1326. for the 2019 benefit year, and thereby
Medicaid Services, HHS. avoid having to establish their own
FOR FURTHER INFORMATION CONTACT:
ACTION: Notice. programs. Issuers and providers can use
William Parham at (410) 786–4669.
SUMMARY: The Centers for Medicare & SUPPLEMENTARY INFORMATION: the alternative reporting requirements
Medicaid Services (CMS) is announcing for mental and behavioral health records
Contents described herein to comply with State
an opportunity for the public to
comment on CMS’ intention to collect This notice sets out a summary of the privacy laws. Form Number: CMS–
information from the public. Under the use and burden associated with the 10401 (OMB control number: 0938–
Paperwork Reduction Act of 1995 (the following information collections. More 1155); Frequency: Yearly; Affected
PRA), federal agencies are required to detailed information can be found in Public: State, Local, or Tribal
publish notice in the Federal Register each collection’s supporting statement Governments; Number of Respondents:
concerning each proposed collection of and associated materials (see 700; Total Annual Responses:
information (including each proposed ADDRESSES). 11,700,000,287; Total Annual Hours:
extension or reinstatement of an existing CMS–10401 Standards Related to 5,828,037. (For policy questions
collection of information) and to allow Reinsurance, Risk Corridors, and regarding this collection contact Ernest
60 days for public comment on the Risk Adjustment Ayukawa at 410–492–5213.)
proposed action. Interested persons are Under the PRA (44 U.S.C. 3501– Dated: January 2, 2018.
invited to send comments regarding our 3520), federal agencies must obtain William N. Parham, III,
burden estimates or any other aspect of approval from the Office of Management Director, Paperwork Reduction Staff, Office
this collection of information, including and Budget (OMB) for each collection of of Strategic Operations and Regulatory
the necessity and utility of the proposed information they conduct or sponsor. Affairs.
information collection for the proper The term ‘‘collection of information’’ is [FR Doc. 2018–00086 Filed 1–5–18; 8:45 am]
performance of the agency’s functions, defined in 44 U.S.C. 3502(3) and 5 CFR BILLING CODE 4120–01–P
the accuracy of the estimated burden, 1320.3(c) and includes agency requests
ways to enhance the quality, utility, and or requirements that members of the
clarity of the information to be public submit reports, keep records, or DEPARTMENT OF HEALTH AND
collected, and the use of automated provide information to a third party. HUMAN SERVICES
collection techniques or other forms of Section 3506(c)(2)(A) of the PRA
information technology to minimize the requires federal agencies to publish a Food and Drug Administration
information collection burden. 60-day notice in the Federal Register [Docket No. FDA–2011–N–0231]
DATES: Comments must be received by concerning each proposed collection of
March 9, 2018. information, including each proposed Agency Information Collection
ADDRESSES: When commenting, please extension or reinstatement of an existing Activities; Submission for Office of
reference the document identifier or collection of information, before Management and Budget Review;
OMB control number. To be assured submitting the collection to OMB for Adverse Experience Reporting for
consideration, comments and approval. To comply with this Licensed Biological Products; and
recommendations must be submitted in requirement, CMS is publishing this General Records
any one of the following ways: notice.
1. Electronically. You may send your AGENCY: Food and Drug Administration,
Information Collection HHS.
comments electronically to http://
www.regulations.gov. Follow the 1. Type of Information Collection ACTION: Notice.
instructions for ‘‘Comment or Request: Revision of a previously
approved collection; Title of SUMMARY: The Food and Drug
Submission’’ or ‘‘More Search Options’’
Information Collection: Standards Administration (FDA or we) is
to find the information collection
Related to Reinsurance, Risk Corridors, announcing that a proposed collection
document(s) that are accepting
and Risk Adjustment; Use: The data of information has been submitted to the
comments.
2. By regular mail. You may mail collection and reporting requirements Office of Management and Budget
written comments to the following described below will be used by HHS to (OMB) for review and clearance under
address: CMS, Office of Strategic run the permanent risk adjustment the Paperwork Reduction Act of 1995.
program, including validation of data DATES: Fax written comments on the
sradovich on DSK3GMQ082PROD with NOTICES
Operations and Regulatory Affairs
Division of Regulations Development; submitted by issuers, on behalf of States collection of information by February 7,
Attention: Document Identifier/OMB that requested HHS to run it for them. 2018.
Control Number lll, Room C4–26– Risk adjustment is one of three (3) ADDRESSES: To ensure that comments on
05, 7500 Security Boulevard, Baltimore, market stability programs established by the information collection are received,
Maryland 21244–1850. the Patient Protection and Affordable OMB recommends that written
To obtain copies of a supporting Care Act and is intended to mitigate the comments be faxed to the Office of
statement and any related forms for the impact of adverse selection in the Information and Regulatory Affairs,
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![Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices 821
retained. The recordkeeping obtained from the FDA’s database requests from 40 manufacturers for
requirements for §§ 610.12(g), system, there were 93 manufacturers of waivers under § 600.90 (including
610.13(a)(2), 610.18(d), 21 CFR 680.2(f), biological products. This number §§ 600.80(h)(2) and 600.81(b)(2)), of
and 680.3(f) are approved under OMB excludes those manufacturers who which 79 were granted. The hours per
control number 0910–0139. produce Whole Blood, components of response are based on FDA experience.
Respondents to this collection of Whole Blood, or in-vitro diagnostic The burden hours required to complete
information include manufacturers of licensed products, because of the the MedWatch Form (Form FDA 3500A)
biological products (including blood exemption under § 600.80(m). The total for § 600.80(c)(1), (e), and (f) are
and blood components) and any person reported under OMB control number
annual responses are based on the
whose name appears on the label of a 0910–0291.
number of submissions received by FDA
licensed biological product. In table 1,
the number of respondents is based on in FY 2016. There were an estimated In the Federal Register of July 18,
the estimated number of manufacturers 125,371 15-day Alert reports, 180,580 2017 (82 FR 32836), FDA published a
that are subject to those regulations or periodic reports, and 677 lot 60-day notice requesting public
that submitted the required information distribution reports submitted to FDA. comment on the proposed collection of
to the Center for Biologics Evaluation The number of 15-day Alert reports for information. No comments were
and Research and Center for Drugs postmarketing studies under § 600.80(e) received.
Evaluation and Research, FDA, in fiscal is included in the total number of 15- FDA estimates the burden of this
year (FY) 2016. Based on information day Alert reports. FDA received 81 collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average burden
Number of Total annual
21 CFR Section responses per per response (in Total hours
respondents responses
respondent hours)
600.80(c)(1), 600.80(d), and 600.80(e);
postmarketing 15-day Alert reports .... 93 1,348.07 125,371 1 125,371
600.82; notification of discontinuance or
interruption in manufacturing .............. 18 1.61 29 2 58
600.80(c)(2); periodic adverse experi-
ence reports ....................................... 93 1,941.72 180,580 28 5,056,240
600.81 Distribution Reports ................... 93 7.28 677 1 677
600.80(h)(2), 600.81(b)(2), and 600.90;
waiver requests .................................. 40 2.03 81 1 81
Total ................................................ .............................. .............................. .............................. .............................. 5,182,427
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In table 2 the number of respondents listed for § 600.12(a) through (e) annual average of lots released in FY
is based on the number of excluding (b)(2) is estimated to be 114. 2016 (7,198), number of recalls made
manufacturers subject to those This number excludes manufacturers of (575), and total number of adverse
regulations. Based on information blood and blood components because experience reports received (305,951) in
obtained from FDA’s database system, their burden hours for recordkeeping FY 2016. The hours per record are based
there were 263 licensed manufacturers have been reported under § 606.160 in on FDA experience.
of biological products in FY 2016. OMB control number 0910–0116. The FDA estimates the burden of this
However, the number of recordkeepers total annual records is based on the recordkeeping as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR Section records per Total hours
recordkeepers records recordkeeper
recordkeeper (in hours)
600.12 2; maintenance of records ........................................ 114 63.14 7,198 32 230,336
600.12(b)(2); recall records ................................................. 263 2.19 575 24 13,800
600.80(c)(1) and 600.80(k) .................................................. 93 3,289.79 305,951 1 305,951
Total .............................................................................. ........................ ........................ ........................ ........................ 550,087
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
sradovich on DSK3GMQ082PROD with NOTICES
The burden for this information increased our reporting and Dated: January 2, 2018.
collection has changed since the last recordkeeping burden estimates. Leslie Kux,
OMB approval. Because of an increase Associate Commissioner for Policy.
in the number of AER reports we have [FR Doc. 2018–00095 Filed 1–5–18; 8:45 am]
received during the past 3years, we have BILLING CODE 4164–01–P
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Document Created: 2018-01-06 02:31:57
Document Modified: 2018-01-06 02:31:57
| 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 February 7, 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 819 |
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