82 FR 32836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 136 (July 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 136 (July 18, 2017)
| Page Range | 32836-32838 | |
| FR Document | 2017-15004 |
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)] [Notices] [Pages 32836-32838] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15004] [[Page 32836]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0231] Agency Information Collection Activities; Proposed Collection; Comment Request; 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 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 proposed extension of the collection of information concerning requirements relating to FDA's Adverse Experience Reporting System (FAERS) for licensed biological products, and general records associated with the manufacture and distribution of biological products. DATES: Submit either electronic or written comments on the collection of information by September 18, 2017. 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 September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 18, 2017. 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-2011-N-0231 for ``Adverse Experience Reporting for Licensed Biological Products; and General Records.'' 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: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [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 these topics: (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 [[Page 32837]] 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. 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. Sec. 600.80(h)(1) and 600.80(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 retained. The recordkeeping requirements for Sec. Sec. 610.12(g), 610.13(a)(2), 610.18(d), 680.2(f), and 21 CFR 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 [[Page 32838]] 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. 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 Total hours respondents respondent responses (in hours) ---------------------------------------------------------------------------------------------------------------- 600.80(c)(1), 600.80(d), and 93 1,348.07 125,371 1 125,371 600.80(e); postmarketing 15-day Alert reports.................. 600.82; notification of 18 1.61 29 2 58 discontinuance or interruption in manufacturing............... 600.80(c)(2); periodic adverse 93 1,941.72 180,580 28 5,056,240 experience reports............. 600.81 Distribution Reports..... 93 7.28 677 1 677 600.80(h)(2), 600.81(b)(2), and 40 2.03 81 1 81 600.90; waiver requests........ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 5,182,427 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection 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 3 years, we have increased our reporting and recordkeeping burden estimates. Dated: July 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15004 Filed 7-17-17; 8:45 am] BILLING CODE 4164-01-P
![32836 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your both copies to the Dockets Management
HUMAN SERVICES comment does not include any Staff. If you do not wish your name and
confidential information that you or a contact information to be made publicly
Food and Drug Administration third party may not wish to be posted, available, you can provide this
[Docket No. FDA–2011–N–0231] such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
Agency Information Collection confidential business information, such must identify this information as
Activities; Proposed Collection; as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Comment Request; Adverse that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Experience Reporting for Licensed information, or other information that except in accordance with 21 CFR 10.20
Biological Products; and General identifies you in the body of your and other applicable disclosure law. For
Records comments, that information will be more information about FDA’s posting
posted on https://www.regulations.gov. of comments to public dockets, see 80
AGENCY: Food and Drug Administration, • If you want to submit a comment FR 56469, September 18, 2015, or access
HHS. with confidential information that you the information at: https://www.gpo.gov/
ACTION: Notice. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
SUMMARY: The Food and Drug
written/paper submission and in the Docket: For access to the docket to
Administration (FDA or Agency) is
manner detailed (see ‘‘Written/Paper read background documents or the
announcing an opportunity for public
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
comment on the proposed collection of
certain information by the Agency. Written/Paper Submissions received, go to https://
Under the Paperwork Reduction Act of www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
1995 (PRA), Federal Agencies are follows: heading of this document, into the
required to publish notice in the • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
Federal Register concerning each written/paper submissions): Dockets
proposed collection of information, and/or go to the Dockets Management
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
including each proposed extension of an Drug Administration, 5630 Fishers
existing collection of information, and Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
to allow 60 days for public comment in • For written/paper comments
response to the notice. This notice submitted to the Dockets Management Domini Bean, Office of Operations,
solicits comments on the proposed Staff, FDA will post your comment, as Food and Drug Administration, Three
extension of the collection of well as any attachments, except for White Flint North, 10A63, 11601
information concerning requirements information submitted, marked and Landsdown St., North Bethesda, MD
relating to FDA’s Adverse Experience identified, as confidential, if submitted 20852, 301–796–5733, PRAStaff@
Reporting System (FAERS) for licensed as detailed in ‘‘Instructions.’’ fda.hhs.gov.
biological products, and general records Instructions: All submissions received SUPPLEMENTARY INFORMATION: Under the
associated with the manufacture and must include the Docket No. FDA– PRA (44 U.S.C. 3501–3520), Federal
distribution of biological products. 2011–N–0231 for ‘‘Adverse Experience Agencies must obtain approval from the
DATES: Submit either electronic or Reporting for Licensed Biological Office of Management and Budget
written comments on the collection of Products; and General Records.’’ (OMB) for each collection of
information by September 18, 2017. Received comments, those filed in a information they conduct or sponsor.
ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be ‘‘Collection of information’’ is defined
as follows. Please note that late, placed in the docket and, except for in 44 U.S.C. 3502(3) and 5 CFR
untimely filed comments will not be those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
considered. Electronic comments must Submissions,’’ publicly viewable at or requirements that members of the
be submitted on or before September 18, https://www.regulations.gov or at the public submit reports, keep records, or
2017. The https://www.regulations.gov Dockets Management Staff between 9 provide information to a third party.
electronic filing system will accept a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44
comments until midnight Eastern Time Friday. U.S.C. 3506(c)(2)(A)) requires Federal
at the end of September 18, 2017. • Confidential Submissions—To Agencies to provide a 60-day notice in
Comments received by mail/hand submit a comment with confidential the Federal Register concerning each
delivery/courier (for written/paper information that you do not wish to be proposed collection of information,
submissions) will be considered timely made publicly available, submit your including each proposed extension of an
if they are postmarked or the delivery comments only as a written/paper existing collection of information,
service acceptance receipt is on or submission. You should submit two before submitting the collection to OMB
before that date. copies total. One copy will include the for approval. To comply with this
information you claim to be confidential requirement, FDA is publishing notice
Electronic Submissions with a heading or cover note that states of the proposed collection of
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
following way: CONFIDENTIAL INFORMATION.’’ The With respect to the following
• Federal eRulemaking Portal: Agency will review this copy, including collection of information, FDA invites
sradovich on DSK3GMQ082PROD with NOTICES
https://www.regulations.gov. Follow the the claimed confidential information, in comments on these topics: (1) Whether
instructions for submitting comments. its consideration of comments. The the proposed collection of information
Comments submitted electronically, second copy, which will have the is necessary for the proper performance
including attachments, to https:// claimed confidential information of FDA’s functions, including whether
www.regulations.gov will be posted to redacted/blacked out, will be available the information will have practical
the docket unchanged. Because your for public viewing and posted on utility; (2) the accuracy of FDA’s
comment will be made public, you are https://www.regulations.gov. Submit estimate of the burden of the proposed
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![32838 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
whose name appears on the label of a produce Whole Blood, components of requests from 40 manufacturers for
licensed biological product. In table 1, Whole Blood, or in-vitro diagnostic waivers under § 600.90 (including
the number of respondents is based on licensed products, because of the §§ 600.80(h)(2) and 600.81(b)(2)), of
the estimated number of manufacturers exemption under § 600.80(m). The total which 79 were granted. The hours per
that are subject to those regulations or annual responses are based on the response are based on FDA experience.
that submitted the required information number of submissions received by FDA The burden hours required to complete
to the Center for Biologics Evaluation in FY 2016. There were an estimated the MedWatch Form (Form FDA 3500A)
and Research and Center for Drugs 125,371 15-day Alert reports, 180,580 for § 600.80(c)(1), (e), and (f) are
Evaluation and Research, FDA, in fiscal periodic reports, and 677 lot reported under OMB control number
year (FY) 2016. Based on information distribution reports submitted to FDA.
0910–0291.
obtained from the FDA’s database The number of 15-day Alert reports for
system, there were 93 manufacturers of postmarketing studies under § 600.80(e) FDA estimates the burden of this
biological products. This number is included in the total number of 15- collection of information as follows:
excludes those manufacturers who day Alert reports. FDA received 81
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section responses per Total hours
respondents responses response
respondent (in 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 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 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.
The burden for this information Dated: July 12, 2017. DEPARTMENT OF HEALTH AND
collection has changed since the last Anna K. Abram, HUMAN SERVICES
OMB approval. Because of an increase Deputy Commissioner for Policy, Planning,
in the number of AER reports we have Legislation, and Analysis. Food and Drug Administration
received during the past 3 years, we [FR Doc. 2017–15004 Filed 7–17–17; 8:45 am] [Docket No. FDA–2016–N–0002]
sradovich on DSK3GMQ082PROD with NOTICES
have increased our reporting and BILLING CODE 4164–01–P
recordkeeping burden estimates. Hospira, Inc. et al.; Withdrawal of
Approval of 44 New Drug Applications
and 158 Abbreviated New Drug
Applications; Correction
AGENCY: Food and Drug Administration,
HHS.
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Document Created: 2018-10-24 11:25:54
Document Modified: 2018-10-24 11:25:54
| 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 September 18, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 32836 |
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