Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests, 18984-18985 [2020-06996]

Download as PDF 18984 Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Recommendations To Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components; Agency Guidance jbell on DSKJLSW7X2PROD with NOTICES OMB Control Number 0910–0681— Extension Under § 630.3(h) (21 CFR 630.3(h)), a list is set forth of relevant transfusiontransmitted infections (RTTIs) (§ 630.3(h)(1)) and the conditions under which a transfusion-transmitted infection (TTI) would meet the definition of an RTTI (§ 630.3(h)(2)). The list of RTTIs under § 630.3(h)(1) includes, among other things, the following: Trypanosoma cruzi (Chagas), Creutzfeldt Jacob Disease (CJD)/variant Creutzfeldt Jacob Disease (vCJD), plasmodium species (malaria), and West Nile virus. The RTTIs FDA has identified thus far under § 630.3(h)(2) include Zika virus and babesiosis. In addition, FDA has determined Ebola virus to be a TTI identified under § 630.3(l). FDA has issued several guidance documents with recommendations regarding the RTTIs or TTIs including Chagas, babesiosis, Zika virus, West Nile virus, Ebola virus, malaria, CJD and vCJD, human immunodeficiency virus (HIV) and human T-lymphotropic virus, types I and II (HTLV). The Chagas, babesiosis, Zika virus, West Nile virus, and HTLV guidance documents provide recommendations for consignee and physician notification relating to donors that tested reactive for these infections. In addition, a blood establishment may receive information from a donor following collection that reveals the donor had a risk factor for an RTTI or TTI at the time of collection and should have been deferred for the risk factor. FDA has recommended, in the following guidance documents, that such a blood collection establishment notify the consignee regarding the distributed blood components that are potentially at-risk for an RTTI or TTI. In some cases, we recommend that if the blood VerDate Sep<11>2014 17:45 Apr 02, 2020 Jkt 250001 was transfused, the consignee notify the transfusion recipient’s physician of record regarding the potential risk. This recommendation is included in Ebola virus, malaria, CJD and vCJD, and HIV guidance documents. These guidance documents are available from our website at https://www.fda.gov/ vaccines-blood-biologics/biologicsguidances/blood-guidances. In the Federal Register of January 7, 2020 (85 FR 716), we published a 60day notice requesting public comment on the proposed collection of information. For purposes of estimating burden under the PRA, we provided an estimate of one response and one burden hour annually. As we discussed in our 60-day notice, although such notifications are rare, we believe that these notification practices would be part of the usual and customary business practice for blood establishments and consignees in addressing the RTTIs or TTIs under the regulations. In addition, we believe respondents would have already developed standard operating procedures for notifying consignees and the recipient’s physician of record regarding distributed blood components potentially at risk for a TTI. No comments were received in response to our 60-day notice, and we therefore retain this estimate. As other relevant transfusion-transmitted infections are determined under § 630.3, we may continue to issue guidance accordingly, and, if approved, intend the information collections to be included under this OMB control number. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. These guidance documents, as applicable, also refer to previously approved FDA collections of information. The collections of information in 21 CFR parts 601 and 640, and Form FDA 356h have been approved under OMB control number 0910–0338; the collections of information in 21 CFR parts 606 and 630 have been approved under OMB control number 0910–0116; the collections of information in 21 CFR 606.171 have been approved under OMB control number 0910–0458. Dated: March 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–06986 Filed 4–2–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2066] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by May 4, 2020. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0832. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Certification of Identity; Form FDA 3975 OMB Control Number 0910–0832— Extension This information collection supports Form FDA 3975 entitled ‘‘Certification of Identity,’’ which is used by FDA to identify an individual requesting a particular record under the Freedom of Information Act (FOIA) and the Privacy Act. The form is available from our website at: https://www.fda.gov/ E:\FR\FM\03APN1.SGM 03APN1 18985 Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices RegulatoryInformation/FOI/default.htm, although if an individual requests one, we will send it by mail or email. The form is required only if an individual makes an FOIA request or Privacy Act request for records about himself and has not provided sufficient assurances of identity in the incoming FOIA or Privacy Act request. The FOIA grants the public a right to access Federal records not normally prepared for public distribution. The Privacy Act grants a right of access to members of the public who seek access to one’s own records that are maintained in an Agency’s system of records (i.e., the records are retrieved by that individual’s name or other personal identifier). The statutes overlap, and individuals who request their own records are processed under both statutes. The Agency may need to confirm that the individual making the FOIA or Privacy Act request is indeed the same person named in the Agency records. Respondents to the information collection are asked for certain information including name, citizenship status, social security number, address, date of birth, place of birth, signature, and date of signature. In the Federal Register of November 22, 2019 (84 FR 64539), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received stating it was important that FDA retain the information collection to help protect against potential identity fraud. The comment also suggested that the associated burden for completing and submitting Form FDA 3975 may be lower than estimated, but did not provide alternative figures for us to consider. We therefore retain our burden estimate, which is as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents FDA form No. 3975; Certification of Identity ............................................... 1 There Dated: March 26, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–06996 Filed 4–2–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0731] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and TissueBased Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES 50 Total annual responses 1 50 Average burden per response 0.17 (10 minutes) Total hours 8.5 are no capital costs or operating and maintenance costs associated with this collection of information. Based on Agency data, we have received no more than 50 submissions since establishing the collection in 2017. AGENCY: Number of responses per respondent VerDate Sep<11>2014 17:45 Apr 02, 2020 Jkt 250001 collection of information by May 4, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0543. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, 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. Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice OMB Control Number 0910–0543– Extension Under section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 introduction, transmission, or spread of communicable diseases between the States or possessions or from foreign countries into the States. As derivatives of the human body, all human cells, tissues, and cellular and tissue-based products (HCT/Ps) pose some risk of carrying pathogens that could potentially infect recipients or handlers. FDA has issued regulations related to HCT/Ps involving electronic establishment registration and listing using an electronic system, eligibility determination for donors, and current good tissue practice (CGTP). I. Electronic Establishment Registration and Listing The regulations in part 1271 (21 CFR part 1271) require domestic and foreign establishments that recover, process, store, label, package, or distribute an HCT/P regulated solely under section 361 of the PHS Act and described in § 1271.10(a) (21 CFR 1271.10(a)), or that perform screening or testing of the cell or tissue donor, to register electronically with FDA (§§ 1271.1(a) (21 CFR 1271.1(a)) and 1271.10(b)(1)) and submit a list electronically of each HCT/P manufactured (§§ 1271.1(a) and 1271.10(b)(2)). Section 1271.21(a) (21 CFR 1271.21(a)) requires an establishment to follow certain procedures for initial registration and listing of HCT/Ps, and § 1271.25(a) and (b) (21 CFR 1271.25(a) and (b)) identify the required initial registration and HCT/P listing information. Section 1271.21(b), in brief, requires an annual update of the establishment registration. E:\FR\FM\03APN1.SGM 03APN1

Agencies

[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18984-18985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2066]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Certification of 
Identity for Freedom of Information Act and Privacy Act Requests

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by May 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0832. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

Certification of Identity; Form FDA 3975

OMB Control Number 0910-0832--Extension

    This information collection supports Form FDA 3975 entitled 
``Certification of Identity,'' which is used by FDA to identify an 
individual requesting a particular record under the Freedom of 
Information Act (FOIA) and the Privacy Act. The form is available from 
our website at: https://www.fda.gov/

[[Page 18985]]

RegulatoryInformation/FOI/default.htm, although if an individual 
requests one, we will send it by mail or email. The form is required 
only if an individual makes an FOIA request or Privacy Act request for 
records about himself and has not provided sufficient assurances of 
identity in the incoming FOIA or Privacy Act request.
    The FOIA grants the public a right to access Federal records not 
normally prepared for public distribution. The Privacy Act grants a 
right of access to members of the public who seek access to one's own 
records that are maintained in an Agency's system of records (i.e., the 
records are retrieved by that individual's name or other personal 
identifier). The statutes overlap, and individuals who request their 
own records are processed under both statutes. The Agency may need to 
confirm that the individual making the FOIA or Privacy Act request is 
indeed the same person named in the Agency records. Respondents to the 
information collection are asked for certain information including 
name, citizenship status, social security number, address, date of 
birth, place of birth, signature, and date of signature.
    In the Federal Register of November 22, 2019 (84 FR 64539), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received stating it was 
important that FDA retain the information collection to help protect 
against potential identity fraud. The comment also suggested that the 
associated burden for completing and submitting Form FDA 3975 may be 
lower than estimated, but did not provide alternative figures for us to 
consider. We therefore retain our burden estimate, which is as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          FDA form No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
3975; Certification of Identity.              50               1              50            0.17             8.5
                                                                                    (10 minutes)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on Agency data, we have received no more than 50 submissions 
since establishing the collection in 2017.

    Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06996 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P

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