82 FR 58808 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 239 (December 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 239 (December 14, 2017)
| Page Range | 58808-58810 | |
| FR Document | 2017-26933 |
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)] [Notices] [Pages 58808-58810] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26933] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0279] Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements 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 information collection in the regulations on the Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements. DATES: Submit either electronic or written comments on the collection of information by February 12, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must [[Page 58809]] be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 12, 2018. 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-0279 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements.'' 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, 10A-12M, 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 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. Prescription Drug Marketing Act of 1987--Administrative Procedures, Policies, and Requirements OMB Control Number 0910-0435--Extension This information collection supports FDA regulations. Specifically, regulations codified at 21 CFR part 203 implement the Prescription Drug Marketing Act of 1987 (PDMA). The PDMA was intended to ensure safe and effective drug products and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold to consumers. The reporting and recordkeeping requirements found in the regulations are intended to help achieve the following goals: (1) To ban the reimportation of prescription drugs produced in the United States, except when reimported by the manufacturer or under FDA authorization for emergency medical care; (2) to ban the sale, purchase, or trade, or the offer to sell, purchase, or trade, of any prescription drug sample; (3) to limit the distribution of drug samples to practitioners licensed or authorized to prescribe such drugs or to pharmacies of [[Page 58810]] hospitals or other healthcare entities at the request of a licensed or authorized practitioner; (4) to require licensed or authorized practitioners to request prescription drug samples in writing; (5) to mandate storage, handling, and recordkeeping requirements for prescription drug samples; (6) to prohibit, with certain exceptions, the sale, purchase, or trade, or the offer to sell, purchase, or trade, of prescription drugs that were purchased by hospitals or other healthcare entities or that were donated or supplied at a reduced price to a charitable organization; and (7) to require unauthorized wholesale distributors to provide, prior to the wholesale distribution of a prescription drug to another wholesale distributor or retail pharmacy, a statement identifying each prior sale, purchase, or trade of the drug. In the tables below we have listed specific regulatory provisions that include information collection. We estimate the burden of the information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total annual burden per 21 CFR section/activity respondents responses per responses response (in Total hours respondent hours) ---------------------------------------------------------------------------------------------------------------- 203.11--Reimportation........... 1 1 1 0.5 1 203.30(a)(1) and (b)--Drug 61,961 12 743,532 0.06 44,612 sample requests................ 203.30(a)(3), (a)(4), and (c)-- 61,961 12 743,532 0.06 44,612 Drug sample receipts........... 203.31(a)(1) and (b)--Drug 232,355 135 31,367,925 0.04 1,254,717 sample requests................ 203.31(a)(3), (a)(4), and (c)-- 232,355 135 31,367,925 0.03 941,038 Drug sample receipts........... 203.37(a)--Falsification of 50 4 200 0.25 50 records........................ 203.37(b)--Loss or theft of 50 40 2,000 0.25 500 samples........................ 203.37(c)--Convictions.......... 1 1 1 1 1 203.37(d)--Contact person....... 50 1 50 0.08 4 203.39(g)--Reconciliation report 1 1 1 1 1 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 2,285,536 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Average burden Number of Number of Total annual per 21 CFR section/activity recordkeepers records per records recordkeeping Total hours recordkeeper (in hours) ---------------------------------------------------------------------------------------------------------------- 203.23(a) and (b)--Returned 31,676 5 158,380 0.25 39,595 drugs.......................... 203.23(c)--Returned drugs 31,676 5 158,380 0.08 12,670 documentation.................. 203.30(a)(2) and 203.31(a)(2)-- 2,208 100 220,800 0.5 110,400 Practitioner verification...... 203.31(d)(1) and (d)(2)-- 2,208 1 2,208 40 88,320 Inventory record and reconciliation report.......... 203.31(d)(4)--Investigation of 442 1 442 24 10,608 discrepancies and losses....... 203.31(e)--Representatives lists 2,208 1 2,208 1 2,208 203.34--Administrative systems.. 90 1 90 40 3,600 203.37(a)--Falsification of drug 50 4 200 6 1,200 sample records................. 203.37(b)--Loss or theft of drug 50 40 2,000 6 12,000 samples........................ 203.39(d)--Destroyed or returned 65 1 65 1 65 drug samples................... 203.39(e)--Donated drug samples. 3,221 1 3,221 0.5 1,611 203.39(f)--Distribution of 3,221 1 3,221 8 25,768 donated drug samples........... 203.39(g)--Drug samples donated 3,221 1 3,221 8 25,768 to charitable institutions..... 203.50(a)--Drug origin statement 125 100 12,500 0.17 2,125 203.50(b)--Drug origin statement 125 100 12,500 0.5 6,250 retention...................... 203.50(d)--Authorized 691 1 691 2 1,382 distributors of record......... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 343,570 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection, we have retained the currently approved estimated burden. Dated: December 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26933 Filed 12-13-17; 8:45 am] BILLING CODE 4164-01-P
![58808 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
requirements conducted or sponsored certain reporting requirements for acquisitions provided under the prior
by the Board. Board-approved financial companies. The Board created written consent provisions generally
collections of information are the FR XX–1 reporting form to collect would not be deemed confidential, but
incorporated into the official OMB information required to be submitted by that some such information may be of
inventory of currently approved Regulation XX. the type that could be withheld under
collections of information. Copies of the Legal authorization and exemption 4 on a case-by-case basis,
Paperwork Reduction Act Submission, confidentiality: This information under the standards enumerated above.
supporting statements and approved collection is authorized by section 14 of Current actions: On August 16, 2017,
collection of information instrument(s) the Bank Holding Company Act (12 the Board published a notice in the
are placed into OMB’s public docket U.S.C. 1852(d)) and Regulation XX (12 Federal Register (82 FR 38906)
files. The Federal Reserve may not CFR part 251). The obligation of requesting public comment for 60 days
conduct or sponsor, and the respondent financial companies to comply with the on the extension, without revision, of
is not required to respond to, an consolidated liabilities reporting the FR XX and FR XX–1. The comment
information collection that has been requirement is mandatory. Compliance period for this notice expired on
extended, revised, or implemented on or by financial companies with the October 16, 2017. The Board did not
after October 1, 1995, unless it displays transactional reporting requirements is receive any comments. The information
a currently valid OMB control number. required in order to obtain the benefit of collection will be extended as proposed.
Board consent to consummation of the
Final Approval Under OMB Delegated Board of Governors of the Federal Reserve
transactions. System, December 11, 2017.
Authority of the Extension for Three Section 251.6 and FR XX–1. As noted,
Years, Without Revision, of the Ann E. Misback,
the required reporting of calendar year-
Following Report end liabilities under section 251.6 of Secretary of the Board.
Regulation XX can be satisfied by many [FR Doc. 2017–26962 Filed 12–13–17; 8:45 am]
Report title: Reporting Requirements
Associated with Regulation XX financial companies through their BILLING CODE 6210–01–P
Concentration Limit; Financial continued reporting of consolidated
Company (as defined) Report of financial information to the Board or
Consolidated Liabilities. other appropriate Federal banking DEPARTMENT OF HEALTH AND
Agency form number: FR XX; FR XX– agency though the various reports listed HUMAN SERVICES
1. above. The information collected on
OMB control number: 7100–0363. those forms has been the subject of Food and Drug Administration
Frequency: Event-generated; annual. separate authorization and [Docket No. FDA–2011–N–0279]
Respondents: Insured depository confidentiality determinations. With
institutions, bank holding companies, regard to the collection of the specific Agency Information Collection
foreign banking organizations, savings information at issue, calendar year-end Activities; Proposed Collection;
and loan holding companies, companies liabilities (including as collected on the Comment Request; Prescription Drug
that control insured depository FR XX–1), such information generally is Marketing Act of 1987; Administrative
institutions, and nonbank financial not considered confidential, but some Procedures, Policies, and
companies supervised by the Board; information, depending on the Requirements
U.S. and foreign financial companies circumstances, may be the type of
that do not otherwise report confidential commercial and financial AGENCY: Food and Drug Administration,
consolidated financial information to information that may be withheld under HHS.
the Board or other appropriate Federal exemption 4 of the Freedom of ACTION: Notice.
banking agency. Information Act (FOIA) (5 U.S.C
SUMMARY: The Food and Drug
Estimated number of respondents: FR 552(b)(4)). As required information, it
Administration (FDA or Agency) is
XX (Section 251.4(b)): 1; FR XX (Section may be withheld under exemption 4 on
announcing an opportunity for public
251.4(c)): 1; FR XX–1: 43. a case-by-case basis only if public
Estimated average hours per response: comment on the proposed collection of
disclosure could result in substantial
FR XX (Section 251.4(b)): 10, FR XX competitive harm to the submitting certain information by the Agency.
(Section 251.4(c)): 10; FR XX–1: 2. institution. Any request from a Under the Paperwork Reduction Act of
Estimated annual burden hours: FR submitter for confidential treatment 1995 (PRA), Federal Agencies are
XX (Section 251.4(b)): 10; FR XX should be accompanied by a detailed required to publish notice in the
(Section 251.4(c)): 10; FR XX–1: 86 (106 justification for confidentiality. Federal Register concerning each
total). Section 251.4. The information proposed collection of information,
General description of report: The collected under section 251.4 (under including each proposed extension of an
Board adopted Regulation XX to both its prior written consent provision existing collection of information, and
implement section 14 of the Bank for individual transactions and the to allow 60 days for public comment in
Holding Company Act of 1956 (BHC general consent authority) consists of (1) response to the notice. This notice
Act), which was added by section 622 a description of the acquisition and (2) solicits comments on the information
of the Dodd-Frank Wall Street Reform the change in and resultant aggregate collection in the regulations on the
and Consumer Protection Act (Dodd- amount of financial company liabilities. Prescription Drug Marketing Act of
Frank Act). Section 14 established a The reported liabilities information, in 1987; Administrative Procedures,
financial sector concentration limit that like fashion to the liabilities information Policies, and Requirements.
sradovich on DSK3GMQ082PROD with NOTICES
generally prohibits a financial company reported under section 251.6, generally DATES: Submit either electronic or
from merging or consolidating with, or is not considered confidential but, written comments on the collection of
otherwise acquiring, another company if depending on the circumstances, may information by February 12, 2018.
the resulting company’s liabilities upon be the type of confidential commercial ADDRESSES: You may submit comments
consummation would exceed 10 percent and financial information that may be as follows. Please note that late,
of the aggregate liabilities of all financial withheld under exemption 4 of FOIA. untimely filed comments will not be
companies. Regulation XX established The description of the individual considered. Electronic comments must
VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1](https://thefederalregister.org/doc/82_FR_59047/page/1.svg)
![58810 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
hospitals or other healthcare entities at sale, purchase, or trade, or the offer to drug to another wholesale distributor or
the request of a licensed or authorized sell, purchase, or trade, of prescription retail pharmacy, a statement identifying
practitioner; (4) to require licensed or drugs that were purchased by hospitals each prior sale, purchase, or trade of the
authorized practitioners to request or other healthcare entities or that were drug. In the tables below we have listed
prescription drug samples in writing; (5) donated or supplied at a reduced price specific regulatory provisions that
to mandate storage, handling, and to a charitable organization; and (7) to include information collection.
recordkeeping requirements for require unauthorized wholesale
prescription drug samples; (6) to distributors to provide, prior to the We estimate the burden of the
prohibit, with certain exceptions, the wholesale distribution of a prescription information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section/activity responses per Total hours
respondents responses response
respondent (in hours)
203.11—Reimportation ........................................................ 1 1 1 0.5 1
203.30(a)(1) and (b)—Drug sample requests ..................... 61,961 12 743,532 0.06 44,612
203.30(a)(3), (a)(4), and (c)—Drug sample receipts ........... 61,961 12 743,532 0.06 44,612
203.31(a)(1) and (b)—Drug sample requests ..................... 232,355 135 31,367,925 0.04 1,254,717
203.31(a)(3), (a)(4), and (c)—Drug sample receipts ........... 232,355 135 31,367,925 0.03 941,038
203.37(a)—Falsification of records ...................................... 50 4 200 0.25 50
203.37(b)—Loss or theft of samples ................................... 50 40 2,000 0.25 500
203.37(c)—Convictions ........................................................ 1 1 1 1 1
203.37(d)—Contact person .................................................. 50 1 50 0.08 4
203.39(g)—Reconciliation report ......................................... 1 1 1 1 1
Total .............................................................................. ........................ ........................ ........................ ........................ 2,285,536
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section/activity records per Total hours
recordkeepers records recordkeeping
recordkeeper (in hours)
203.23(a) and (b)—Returned drugs .................................... 31,676 5 158,380 0.25 39,595
203.23(c)—Returned drugs documentation ......................... 31,676 5 158,380 0.08 12,670
203.30(a)(2) and 203.31(a)(2)—Practitioner verification ..... 2,208 100 220,800 0.5 110,400
203.31(d)(1) and (d)(2)—Inventory record and reconcili-
ation report ....................................................................... 2,208 1 2,208 40 88,320
203.31(d)(4)—Investigation of discrepancies and losses .... 442 1 442 24 10,608
203.31(e)—Representatives lists ......................................... 2,208 1 2,208 1 2,208
203.34—Administrative systems .......................................... 90 1 90 40 3,600
203.37(a)—Falsification of drug sample records ................. 50 4 200 6 1,200
203.37(b)—Loss or theft of drug samples ........................... 50 40 2,000 6 12,000
203.39(d)—Destroyed or returned drug samples ................ 65 1 65 1 65
203.39(e)—Donated drug samples ...................................... 3,221 1 3,221 0.5 1,611
203.39(f)—Distribution of donated drug samples ................ 3,221 1 3,221 8 25,768
203.39(g)—Drug samples donated to charitable institutions 3,221 1 3,221 8 25,768
203.50(a)—Drug origin statement ....................................... 125 100 12,500 0.17 2,125
203.50(b)—Drug origin statement retention ........................ 125 100 12,500 0.5 6,250
203.50(d)—Authorized distributors of record ....................... 691 1 691 2 1,382
Total .............................................................................. ........................ ........................ ........................ ........................ 343,570
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information Dated: December 8, 2017.
collection, we have retained the Leslie Kux,
currently approved estimated burden. Associate Commissioner for Policy.
[FR Doc. 2017–26933 Filed 12–13–17; 8:45 am]
BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 PO 00000 Frm 00019 Fmt 4703 Sfmt 9990 E:\FR\FM\14DEN1.SGM 14DEN1](https://thefederalregister.org/doc/82_FR_59047/page/3.svg)
Document Created: 2018-10-25 10:53:39
Document Modified: 2018-10-25 10:53:39
| 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 February 12, 2018. | |
| 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] | |
| FR Citation | 82 FR 58808 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR