83 FR 15147 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 68 (April 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 68 (April 9, 2018)
| Page Range | 15147-15148 | |
| FR Document | 2018-07145 |
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)] [Notices] [Pages 15147-15148] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07145] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1069] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830 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: Fax written comments on the collection of information by May 9, 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 0910-0052. 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, [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. Blood Establishment Registration and Product Listing, Form FDA 2830--21 CFR part 607 OMB Control Number 0910-0052--Extension Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, places of business, and all such establishments, among other information, and must submit a list of all drug and all device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution, among other information. In part 607 (21 CFR part 607), FDA has issued regulations implementing these requirements for manufacturers of human blood and blood products. Section 607.20(a), requires, in part, that owners or operators of certain establishments that engage in the manufacture of blood products register and submit a list of every blood product in commercial distribution. Section 607.21 requires the owner or operator of an establishments entering into the manufacturing of blood products to register the establishment within 5 days after beginning such operation and to submit a list of every blood product in commercial distribution at the time. If the owner or operator of the establishment has not previously entered into such operation for which a license is required, registration must follow within 5 days after the submission of a biologics license application. In addition, owners or operators of all establishments so engaged must register annually between October 1 and December 31 and update their blood product listing every June and December. Section 607.22(a) requires, in part, that initial and subsequent registrations and product listings be submitted electronically through the Blood Establishment Registration and Product Listing system or any future superseding electronic system. Section 607.22(b) requires, in part, that requests for a waiver of the requirements of Sec. 607.22 be submitted in writing and include the specific reasons why electronic submission is not reasonable for the registrant. Section 607.22(c) provides that if FDA grants the waiver request, FDA may limit its duration and will specify the terms of the waiver and provide information on how to submit establishment registration, drug listings, other information, and updates, as applicable (e.g., Form FDA 2830). Section 607.25 sets forth the information required for establishment registration and blood product listing. Section 607.26 requires, in part, that certain changes, such as ownership or location changes, be submitted to FDA electronically as an amendment to establishment registration within 5 calendar days of such changes using the FDA Blood Establishment Registration and Product Listing system, or any future superseding electronic system. Section 607.30(a), in part, sets forth the information required from owners or operators of establishments when they update their blood product listing information in June and December of each year (at a minimum). Section 607.31 requires that certain additional blood product listing information be provided upon request by FDA. Section 607.40 requires, in part, that certain foreign blood product establishments comply with the establishment registration and blood product listing information requirements in part 607, subpart B (Sec. Sec. 607.20 through 607.39, 607.40(a) and (b)), and provide the name and address of the establishment and the name of the individual responsible for submitting establishment registration and blood product listing information (Sec. 607.40(c)) [[Page 15148]] as well as the name, address, and phone number of its U.S. agent (Sec. 607.40(d)). This information assists FDA in its inspections of facilities, among other uses, and its collection is essential to the overall regulatory scheme designed to ensure the safety of the Nation's blood supply. Respondents to this collection of information are human blood and plasma donor centers, blood banks, certain transfusion services, other blood product manufacturers, and independent laboratories that engage in quality control and testing for registered blood product establishments. FDA estimates the burden of this collection of information based upon information obtained from the database of FDA's Center for Biologics Evaluation and Research and FDA experience with the blood establishment registration and product listing requirements. In the Federal Register of December 26, 2017 (82 FR 61013), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received no comments. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Activity/form FDA 2830 Number of responses per Total annual Average burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- 607.20(a), 607.21, 607.22, 607.25, Initial Registration.... 115 1 115 1...................... 115 and 607.40. 607.21, 607.22, 607.25, 607.26, Annual Registration..... 2,612 1 2,612 0.5.................... 1,306 607.31, and 607.40. (30 minutes)........... 607.21, 607.25, 607.30(a), 607.31, Product Listing Update.. 200 1 200 0.25................... 50 and 607.40. (15 minutes)........... 607.22(b)............................ Waiver Requests......... 25 .............. 25 1...................... 25 ------------------------------------------------------------------------------------------------------------------ Total............................ ........................ .............. .............. .............. ....................... 1,496 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\There are no capital costs of operating and maintenance costs associated with this collection of information. The burden for this information collection has changed since the last OMB approval. Because of a slight increase in the number of initial registrations and product listing updates FDA has received during the past 3 years, we have increased our reporting burden estimate. Dated: April 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07145 Filed 4-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15147
patterns, devices, manufacturing (OMB) for review and clearance under blood product in commercial
processes, or customer names. the Paperwork Reduction Act of 1995. distribution at the time. If the owner or
Comments containing material for DATES: Fax written comments on the operator of the establishment has not
which confidential treatment is collection of information by May 9, previously entered into such operation
requested must be filed in paper form, 2018. for which a license is required,
must be clearly labeled ‘‘Confidential,’’ registration must follow within 5 days
and must comply with FTC Rule 4.9(c). ADDRESSES: To ensure that comments on after the submission of a biologics
In particular, the written request for the information collection are received, license application. In addition, owners
confidential treatment that accompanies OMB recommends that written or operators of all establishments so
the comment must include the factual comments be faxed to the Office of engaged must register annually between
and legal basis for the request, and must Information and Regulatory Affairs, October 1 and December 31 and update
identify the specific portions of the OMB, Attn: FDA Desk Officer, Fax: 202– their blood product listing every June
comment to be withheld from the public 395–7285, or emailed to oira_ and December.
record. See FTC Rule 4.9(c). Your submission@omb.eop.gov. All
Section 607.22(a) requires, in part,
comment will be kept confidential only comments should be identified with the
that initial and subsequent registrations
if the General Counsel grants your OMB control number 0910–0052. Also
and product listings be submitted
request in accordance with the law and include the FDA docket number found
electronically through the Blood
the public interest. Once your comment in brackets in the heading of this
Establishment Registration and Product
has been posted on the public FTC document.
Listing system or any future superseding
website—as legally required by FTC FOR FURTHER INFORMATION CONTACT: Ila electronic system.
Rule 4.9(b)—we cannot redact or S. Mizrachi, Office of Operations, Food Section 607.22(b) requires, in part,
remove your comment from the FTC and Drug Administration, Three White that requests for a waiver of the
website, unless you submit a Flint North, 10A–12M, 11601 requirements of § 607.22 be submitted
confidentiality request that meets the Landsdown St., North Bethesda, MD in writing and include the specific
requirements for such treatment under 20852, 301–796–7726, PRAStaff@ reasons why electronic submission is
FTC Rule 4.9(c), and the General fda.hhs.gov. not reasonable for the registrant.
Counsel grants that request. SUPPLEMENTARY INFORMATION: In Section 607.22(c) provides that if FDA
The FTC Act and other laws that the compliance with 44 U.S.C. 3507, FDA grants the waiver request, FDA may
Commission administers permit the has submitted the following proposed limit its duration and will specify the
collection of public comments to collection of information to OMB for terms of the waiver and provide
consider and use in this proceeding as review and clearance. information on how to submit
appropriate. The Commission will establishment registration, drug listings,
consider all timely and responsive Blood Establishment Registration and other information, and updates, as
public comments that it receives on or Product Listing, Form FDA 2830—21 applicable (e.g., Form FDA 2830).
before May 9, 2018. For information on CFR part 607 OMB Control Number Section 607.25 sets forth the
the Commission’s privacy policy, 0910–0052—Extension information required for establishment
including routine uses permitted by the Under section 510 of the Federal registration and blood product listing.
Privacy Act, see https://www.ftc.gov/ Food, Drug, and Cosmetic Act (21 U.S.C. Section 607.26 requires, in part, that
site-information/privacy-policy. 360), any person owning or operating an certain changes, such as ownership or
David C. Shonka, establishment that manufactures, location changes, be submitted to FDA
prepares, propagates, compounds, or electronically as an amendment to
Acting General Counsel.
processes a drug or device must register establishment registration within 5
[FR Doc. 2018–07127 Filed 4–6–18; 8:45 am]
with the Secretary of Health and Human calendar days of such changes using the
BILLING CODE 6750–01–P
Services, on or before December 31 of FDA Blood Establishment Registration
each year, his or her name, places of and Product Listing system, or any
business, and all such establishments, future superseding electronic system.
DEPARTMENT OF HEALTH AND among other information, and must Section 607.30(a), in part, sets forth
HUMAN SERVICES submit a list of all drug and all device the information required from owners or
products manufactured, prepared, operators of establishments when they
Food and Drug Administration propagated, compounded, or processed update their blood product listing
by him or her for commercial information in June and December of
[Docket No. FDA–2014–N–1069] distribution, among other information. each year (at a minimum).
In part 607 (21 CFR part 607), FDA has Section 607.31 requires that certain
Agency Information Collection
issued regulations implementing these additional blood product listing
Activities; Submission for Office of
requirements for manufacturers of information be provided upon request
Management and Budget Review;
human blood and blood products. by FDA.
Comment Request; Blood
Section 607.20(a), requires, in part, Section 607.40 requires, in part, that
Establishment Registration and
that owners or operators of certain certain foreign blood product
Product Listing, Form FDA 2830
establishments that engage in the establishments comply with the
AGENCY: Food and Drug Administration, manufacture of blood products register establishment registration and blood
and submit a list of every blood product product listing information
sradovich on DSK3GMQ082PROD with NOTICES
HHS.
ACTION: Notice. in commercial distribution. requirements in part 607, subpart B
Section 607.21 requires the owner or (§§ 607.20 through 607.39, 607.40(a) and
SUMMARY: The Food and Drug operator of an establishments entering (b)), and provide the name and address
Administration (FDA) is announcing into the manufacturing of blood of the establishment and the name of the
that a proposed collection of products to register the establishment individual responsible for submitting
information has been submitted to the within 5 days after beginning such establishment registration and blood
Office of Management and Budget operation and to submit a list of every product listing information (§ 607.40(c))
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![15148 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
as well as the name, address, and phone plasma donor centers, blood banks, and Research and FDA experience with
number of its U.S. agent (§ 607.40(d)). certain transfusion services, other blood the blood establishment registration and
This information assists FDA in its product manufacturers, and product listing requirements.
inspections of facilities, among other independent laboratories that engage in In the Federal Register of December
uses, and its collection is essential to quality control and testing for registered 26, 2017 (82 FR 61013), FDA published
the overall regulatory scheme designed blood product establishments. a 60-day notice requesting public
to ensure the safety of the Nation’s FDA estimates the burden of this comment on the proposed collection of
blood supply. collection of information based upon information. We received no comments.
Respondents to this collection of information obtained from the database FDA estimates the burden of this
information are human blood and of FDA’s Center for Biologics Evaluation collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average burden
Activity/form FDA Number of Total annual
21 CFR section responses per per Total hours
2830 respondents responses
respondent response
607.20(a), 607.21, 607.22, 607.25, Initial Registra- 115 1 115 1 ......................... 115
and 607.40. tion.
607.21, 607.22, 607.25, 607.26, Annual Registra- 2,612 1 2,612 0.5 ...................... 1,306
607.31, and 607.40. tion. (30 minutes) .......
607.21, 607.25, 607.30(a), 607.31, Product Listing 200 1 200 0.25 .................... 50
and 607.40. Update. (15 minutes) .......
607.22(b) ......................................... Waiver Requests 25 ........................ 25 1 ......................... 25
Total ......................................... ............................ ........................ ........................ ........................ ............................ 1,496
1There are no capital costs of operating and maintenance costs associated with this collection of information.
The burden for this information ADDRESSES: To ensure that comments on 350a) requires manufacturers of infant
collection has changed since the last the information collection are received, formula to establish and adhere to
OMB approval. Because of a slight OMB recommends that written quality control procedures, notify us
increase in the number of initial comments be faxed to the Office of when a batch of infant formula that has
registrations and product listing updates Information and Regulatory Affairs, left the manufacturers’ control may be
FDA has received during the past 3 OMB, Attn: FDA Desk Officer, Fax: 202– adulterated or misbranded, and keep
years, we have increased our reporting 395–7285, or emailed to oira_ records of distribution. We also regulate
burden estimate. submission@omb.eop.gov. All the labeling of infant formula under the
Dated: April 3, 2018. comments should be identified with the authority of section 403 of the FD&C Act
OMB control number 0910–0256. Also (21 U.S.C. 343). The purpose of the
Leslie Kux,
include the FDA docket number found labeling requirements is to ensure that
Associate Commissioner for Policy. in brackets in the heading of this
[FR Doc. 2018–07145 Filed 4–6–18; 8:45 am]
consumers have the information they
document. need to prepare and use infant formula
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: appropriately. The regulations for infant
Domini Bean, Office of Operations, formula requirements are codified in 21
DEPARTMENT OF HEALTH AND Food and Drug Administration, Three CFR parts 106 and 107.
HUMAN SERVICES White Flint North, 10A–12M, 11601 To assist respondents with applicable
Landsdown St., North Bethesda, MD reporting provisions found in the
Food and Drug Administration 20852, 301–796–5733, PRAStaff@ regulations, we have developed an
fda.hhs.gov. electronic Form FDA 3978 that allows
[Docket No. FDA–2013–N–0545] SUPPLEMENTARY INFORMATION: In infant formula manufacturers to
compliance with 44 U.S.C. 3507, FDA electronically submit reports and
Agency Information Collection has submitted the following proposed
Activities; Submission for Office of notifications in a standardized format.
collection of information to OMB for Form FDA 3978 prompts respondents to
Management and Budget Review; review and clearance.
Comment Request include information in a standardized
Infant Formula Requirements—21 CFR format and helps respondents organize
AGENCY: Food and Drug Administration, parts 106 and 107 submissions to include only the
HHS. information needed for our review. Draft
ACTION: Notice. OMB Control Number 0910–0256— screenshots of Form FDA 3978 and
Extension instructions are available at https://
SUMMARY: The Food and Drug This information collection supports www.fda.gov/Food/
Administration (FDA) is announcing FDA regulations regarding infant GuidanceRegulation/
that a proposed collection of formula requirements. Statutory FoodFacilityRegistration/
sradovich on DSK3GMQ082PROD with NOTICES
information has been submitted to the requirements for infant formula under InfantFormula/default.htm. Form FDA
Office of Management and Budget the Federal Food, Drug, and Cosmetic 3978 was deployed in 2017 as a pilot by
(OMB) for review and clearance under Act (FD&C Act) are intended to protect FDA and, while informal feedback
the Paperwork Reduction Act of 1995. the health of infants and include a regarding its use has been favorable, we
DATES: Fax written comments on the number of reporting and recordkeeping continue to invite comment. If
collection of information by May 9, requirements. Among other things, manufacturers prefer, however, FDA
2018. section 412 of the FD&C Act (21 U.S.C. continues to accept paper submissions.
VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1](https://thefederalregister.org/doc/83_FR_15215/page/2.svg)
Document Created: 2018-04-07 02:39:16
Document Modified: 2018-04-07 02:39:16
| 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 May 9, 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 15147 |
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